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FDA Advertising and Promotion Enforcement Activities: Update

Alert April 20, 2026

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.

During the first quarter of 2026 FDA’s Center for Drug Evaluation and Research (CDER) Office of Prescription Drug Promotion (OPDP) posted nine untitled letters and one warning letter.

Additionally, CDER issued over thirty warning letters to compounders of drug products purporting to contain semaglutide and/or tirzepatide.

During the same period, FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) posted four untitled letters relating to the advertising and promotion of biologics.

During the same period, the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) posted three warning letters relating to the advertising and promotion of medical devices.

  • Warning Letter to Diasol, Inc. re Diasol Bicarb, Diasol Concentrate, Diasol Additives, and CirtiSol Concentrate (January 29, 2026) (Diasol Warning Letter).
  • Warning Letter to ExThera Medical Corporation re Seraph 100 Microbind Affinity Blood Filter (February 6, 2026) (Seraph 100 Warning Letter).
  • Warning Letter to Longhorn Vaccines and Diagnostics LLC re PrimeStore MTM (February 26, 2026) (PrimeStore MTM Warning Letter).

The Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) did not post any warning letters relating to the advertising and promotion of medical devices during this period.

Office of Prescription Drug Promotion (OPDP)

Untitled Letter to Altor BioScience, LLC (January 7, 2026) and Warning Letter to ImmunityBio, Inc. (March 13, 2026)

OPDP issued an untitled letter to Altor BioScience (Altor), a subsidiary of ImmunityBio, Inc. (ImmunityBio) and a warning letter to ImmunityBio, both alleging that Anktiva’s website and promotional materials misbrand Anktiva because they make false or misleading representations about the drug’s efficacy.

Untitled Letter to Altor BioScience, LLC (January 7, 2026)

OPDP’s untitled letter to Altor BioScience, LLC, alleges that the “Efficacy and Safety” webpage on the Anktiva Healthcare Provider Branded Website and the “Why ANKTIVA®” webpage on the Anktiva Consumer Website misbrand Anktiva by making false or misleading representations about the product’s efficacy. OPDP notes that a previous untitled letter dated September 9, 2025, addressed similar issues.

The untitled letter cites the following claims on the “Efficacy and Safety” webpage:

  • "% Of Responders Who Were Cystectomy Free At 36 Months [–] 84%”
  • “Disease-Specific Overall Survival at 36 Months [–] 99%”

OPDP also notes the “Why ANKTIVA®” webpage includes the following claims:

  • "84% of patients who responded to ANKTIVA were able to keep their bladders at 36 months (n=100)”
  • "99% Disease-Specific Overall Survival at 36 Months”

OPDP alleges these representations misbrand Anktiva by misleadingly implying that QUILT-3.032, the study upon which Anktiva was approved, yielded meaningful conclusions about the drug’s impact on cystectomy avoidance and disease specific survival (DSS), despite the study’s design being incapable of demonstrating improvement on these time-to-event efficacy endpoints. OPDP notes that QUILT-3.032 was a single-arm study evaluating complete response and duration of response data. OPDP further explains that because QUILT-3.032 lacked a comparator arm and cystectomy avoidance and DSS are time-to-event endpoints, the reported results for these measures cannot be meaningfully interpreted without an appropriate comparator. Therefore, FDA’s view is that it is not possible to verify whether the observed outcomes are attributable to Anktiva or to other factors, including the natural progression of the disease.

OPDP acknowledges that the webpages include footnote disclosures indicating the data reflect prespecified secondary endpoints and cautioning that results should be viewed in light of the single-arm study’s limitations. Nevertheless, OPDP concluded that the inclusion of these disclaimers alongside misleading efficacy claims does not cure the overall misleading nature of the promotional communications.

Warning Letter to ImmunityBio, Inc. (March 13, 2026)

OPDP’s warning letter to ImmunityBio, Inc., alleges that a TV ad and podcast are false and misleading and provide evidence that Anktiva is intended for use outside of its approval. OPDP alleges that the materials convey a false sense that Anktiva, which has regulatory approval for a specific form of bladder cancer, is capable of curing or preventing cancer broadly.

False or Misleading Efficacy Claims

OPDP alleges that the TV ad and podcast contain multiple misleading efficacy representations, including claims by the Company’s Executive Chairman such as:

  • “There’s an ability to actually create a cancer vaccine so that we can treat the tumor, and it doesn’t come back.”
  • “[Interleukin-15 (IL-15) is a molecule that] stimulates the natural killer (NK) cell and the T cell…the most important molecule that could cure cancer . . . nobody could figure out how to get IL-15 into your body with a single jab, and that is Anktiva.”
  • We have now discovered and developed this drug . . . approved for bladder cancer, but it actually can treat all cancers . . . is this little vial that you inject subcutaneously that really is on the path to curing the cancer.” In conjunction with the on-screen claim, “Cancer Therapeutic Vaccine (BioShield).”
  • “We have the therapy to prevent cancer if you were exposed to radiation[.]”

OPDP alleges several reasons these claims are misleading:

1) “[T]he representations in the TV ad and podcast misleadingly suggest that Anktiva will allow all NMIBC patients treated with Anktiva to be cancer-free for the long term, when this has not been demonstrated.” The QUILT-3.032 study was a single-arm trial that had 77 adults and yielded a 62% complete response rate. “Of the 62% of patients who responded, 58% had a DOR [duration of response] greater than or equal to 12 months, and 40% had a DOR greater than or equal to 24 months. Therefore, these data do not support that treatment with Anktiva will allow all NMIBC patients to be cancer-free for the long term.”

2) Describing Anktiva as a “single jab” and a “little vial” “misleadingly suggest that Anktiva has a treatment effect as a single agent.” Anktiva’s efficacy “was established based on the results of Cohort A of QUILT-3.032, which only studied Anktiva in combination with BCG [Bacillus Calmette-Guérin], while Cohort C, which evaluated Anktiva as a single agent in the same disease setting, was stopped early for futility.”

3) Claims like “treat the tumor, and it doesn’t come back” and“the most important molecule that could cure cancer…and that is Anktiva” imply “an improvement on the DFS [disease-free survival] endpoint even though the single-arm design of the QUILT-3.032 study was not capable of establishing improvement on this time-to-event efficacy endpoint.”

4) Calling Anktiva a “cancer vaccine” and “the therapy to prevent cancer if you were exposed to radiation” “is false,” as the drug functions as an IL-15 receptor agonist and OPDP is not aware of data suggesting it can prevent cancer.

Lack of Adequate Directions for Use

OPDP identifies certain podcast claims and alleges that they demonstrate an intent to market the drug for indications it has not been approved for and for which its labeling does not contain adequate directions for use:

  • “We have now discovered and developed this drug . . . It’s approved for bladder cancer, but it actually can treat all cancers.”
  • “This thing called checkpoint inhibitors . . . It fails. The only thing that can rescue it is Anktiva .  . . If you have lung cancer, you get radiation, chemotherapy, and you fail. And then you get a checkpoint inhibitor, and you fail. There’s nothing left. The only thing left is this terrible drug called docetaxel . . .”
  • “We have the therapy to prevent cancer if you were exposed to radiation and that’s Anktiva.”

OPDP further alleges that the statements suggest Anktiva is intended for use as an injection, pointing to references to a “single jab” and TV ad imagery of patients receiving injections, even though Anktiva is approved for intravesical use only.

False or Misleading Risk Presentation

OPDP alleges that the TV ad and podcast misleadingly fail to present risks in an appropriate, balanced way. OPDP states that the ad includes several “attention-grabbing visuals of vials of Anktiva” with claims such as “cancer free.” Risk information, however, appears after a fade-to-black transition, a signal that the presentation has ended, and no prompt is provided to alert viewers that material risk disclosures follow.

According to OPDP, the podcast omits risk information entirely, even as it asserts Anktiva’s benefits through statements such as “[t]hink 53+ months duration of response” and “BioShield…[i]t’s approved for bladder cancer…on the path to curing the cancer…” OPDP alleges that the omission of risks creates a misleading understanding of Anktiva’s safety.

Omission of Material Facts

OPDP alleges that the TV ad and podcast fail to include important information about Anktiva’s approved indication, omitting that the drug must be used in conjunction with BCG and is limited to patients with BCG-unresponsive NMIBC. OPDP acknowledges that the TV ad includes the full indication at the end, but OPDP maintains that its placement after a fade-to-black transition does not mitigate the allegedly misleading impression.

OPDP also notes that ImmunityBio failed to submit the podcast on Form FDA 2253 when it was first published, in violation of the submission requirements under 21 CFR 314.81(b)(3)(i).

Untitled Letter to BeOne Medicines USA, Inc. (January 7, 2026)

OPDP’s untitled letter to BeOne Medicines USA, Inc. (BeOne) alleges that a direct-to-consumer (DTC) broadcast advertisement (TV ad) misbrands Brukinsa by making false or misleading representations about the drug’s risks and efficacy.

According to the letter, the TV ad features an older man looking confused with multiple images of questions regarding Chronic Lymphocytic Leukemia (CLL). Then, a voiceover states “[w]ith a CLL diagnosis, there may be moments that seem unclear. But when it’s time for treatment, one thing is clear: Brukinsa.” The man is then pictured ascending a mountain in a gondola, then smiling and looking out over the view from a mountaintop with his family, accompanied by voiceover stating, “See your future clearly again with Brukinsa. Ask your doctor about Brukinsa, the CLL treatment that keeps you in control.”

OPDP alleges that the ad implies that CLL patients receiving Brukinsa treatment can travel long distances or for long periods because they are “in control” of their treatment. OPDP states that patients face the highest risk of adverse reactions when initiating treatment or adjusting dosages, and that regular healthcare provider visits are necessary to monitor the drug’s effectiveness and side effects. OPDP concludes that these claims and visuals are misleading because they suggest patients can continue their regular, active lifestyles, downplaying the drug’s substantial side effects and the need for monitoring.

OPDP also alleges that the TV ad is misleading because it does not present the major statement using both audio and text simultaneously (dual modality) and that “compelling and attention-grabbing visuals,” including embracing family members, shown during the major statement interfere with the viewer’s understanding of the major statement.

Untitled Letter to ARS Pharmaceutical Operations, Inc. (January 23, 2026)

OPDP’s untitled letter to ARS Pharmaceutical Operations, Inc. (ARS) alleges that a DTC broadcast advertisement (TV ad) misbrands Neffy by making false or misleading representations. OPDP states that a previous untitled letter to ARS from September 9, 2025, addressed similar claims.

The letter cites the following claims from the TV ad:

  • “No needles! Goodbye!”
  • “Goodbye, needle fear.”

OPDP alleges that these claims are misleading because they imply patients can entirely avoid injectable treatments for allergic emergencies, which has not been established. In fact, OPDP states that Neffy’s FDA-approved Patient Information directs patients to seek emergency medical care for additional anaphylaxis treatment after administering Neffy if necessary. This follow-up care may involve receiving injectable medications, including epinephrine or other injectable therapies. OPDP acknowledges that the TV ad includes a statement that if additional emergency help is necessary, treatment may include injectable products. Nevertheless, OPDP concludes that this does not cure the misleading nature of the TV ad.

OPDP further alleges that these claims misleadingly imply that Neffy will resolve patients’ anxiety about needles, which has not been shown. OPDP states it has not seen evidence that Neffy treatment affects needle-related anxiety or improves patients’ emotional responses to needles.

OPDP also alleges that the following claims are misleading because they imply that Neffy alone can guarantee that patients with a history of severe allergic reactions do not need to be concerned about or take steps to avoid allergen exposure:

  • “Hello, getaways. Goodbye, stressful days”
  • “Hello, celebration. Goodbye, hesitation”

OPDP further alleges that the TV ad is misleading regarding the storage and handling of Neffy because the ad depicts the Neffy device out of its blister packaging and being placed in a carry case in various bags and a pocket. According to the Patient Information and product labeling, patients should keep Neffy nasal spray in the blister pack until use. OPDP states that this presentation raises public health concerns because each Neffy device is single-use, meaning that accidental activation or device damage from improper storage could prevent patients from receiving Neffy in an emergency.

Untitled Letters to argenx US, Inc. (January 30, 2026)

OPDP issued two untitled letters to argenx US, Inc. (argenx) alleging that two separate DTC television advertisements (TV ads) misbrand Vyvgart Hytrulo by making false or misleading representations about the drug’s risks and benefits.

Vyvgart Hytrulo Untitled Letter (424)

The letter states that the TV ad includes the following claims and depictions:

  • A man in a coffee shop stating, “It’s my treatment, my way” with the SUPER (emphasis original), “VYVGART Hytrulo self-injection for treatment MY way” . . . .[and the] same man, now walking with his family . . . at the top of a mountain range, stating, “It’s travel ready, and can go where I go” with the SUPER (emphasis original), “VYVGART Hytrulo self-injection can go where I go.”
  • A woman in a coffee shop stating, “Self-injection fits my plans” with the SUPER (emphasis original), “VYVGART Hytrulo A self-injection that can fit MY plans . . . .” This is followed by the same woman tailgating in the parking lot of a stadium.

OPDP alleges that these presentations are misleading because the claims and images imply that patients can easily administer Vyvgart Hytrulo while traveling or at sporting events, which oversimplifies the actual administration requirements of the drug. OPDP points out that the FDA-approved Instructions for Use requires multiple detailed steps for proper administration, including allowing the product to reach room temperature over 30 minutes on a clean, flat surface; gathering supplies such as a safety needle, alcohol swab, sharps container, and bandages; hand washing; abdominal injection; and proper syringe disposal. OPDP states that the small message that appears at the bottom of the screen that states “[s]ee Patient Information and Instructions for Use,” does not mitigate this misleading message.

OPDP also alleges the TV ad, including the major statement, fails to disclose important risk information about hypersensitivity and injection-related reactions, including potential allergic reactions and symptoms such as elevated blood pressure, chills, shivering, and chest, stomach, or back pain.

Further, OPDP alleges that the ad is misleading because “the attention-grabbing visuals” shown during the major statement interfere with the viewer’s understanding of the major statement.

Vyvgart Hytrulo Untitled Letter (548)

The letter cites the TV ad as including the following claims together with depictions of patients driving and playing golf:

  • “…and while I still have CIDP [chronic inflammatory demyelinating polyneuropathy], I have a chance to live vividly.”
  • “Vyvgart Hytrulo has been proven to significantly reduce the risk of symptoms getting worse.”
  • “I’m hitting fairways with the fellas. I’m hitting the road with my number one. That’s how we live vividly with Vyvgart Hytrulo”

OPDP alleges that the claims and depictions are misleading because they create the impression that all patients with CIDP who are taking Vyvgart Hytrulo can perform these activities and maintain full functionality without significant limitations, which has not been established. OPDP states that according to the clinical studies section of the Prescribing Information, although clinical trial patients showed statistically significant delays in clinical deterioration compared to placebo, this data does not support the suggestion that all patients can expect to achieve the activity levels shown in the ad.

OPDP also takes issue with the claim that “the risk of arm and leg symptoms getting worse was 61% lower for patients taking VYVGART Hytrulo, compared to patients taking placebo.” OPDP explains that this claim is misleading because the time to clinical deterioration, the primary endpoint of the clinical trial, is not the same as the risk of worsening.

In addition, OPDP points to part of the ad where the golfer states he can use the weekly injection in about 30 seconds. Similar to its allegations in the Vyvgart Hytrulo Untitled Letter (424), OPDP alleges these claims and presentations are misleading because they imply that patients can administer Vyvgart Hytrulo in 30 seconds while participating in activities like golf, which oversimplifies the actual administration requirements of the drug. As noted above, OPDP points out that the FDA-approved Instructions for Use require multiple detailed steps for proper administration and that the accompanying disclaimer does not mitigate this misleading message.

Also like in the Vyvgart Hytrulo Untitled Letter (424), OPDP alleges the TV ad fails to disclose important risk information, and “the attention-grabbing visuals” shown during the major statement interfere with the viewer’s understanding of the major statement.

Untitled Letter to Novo Nordisk Inc. re WEGOVY (February 5, 2026)

OPDP’s untitled letter to Novo Nordisk Inc. (Novo Nordisk) alleges that a DTC television advertisement (TV ad) misbrands WEGOVY® (semaglutide) by making false or misleading representations about the drug’s benefits.

The letter cites the following claims from the TV ad:

  • “The first and only FDA approved GLP-1 weight loss pill.”
  • “Now you can live lighter by losing weight.”
  • “Weight loss with Wegovy isn’t a shortcut. It’s a way forward.”

The letter alleges that these claims and similar on-screen texts are misleading because they suggest that the pill version of Wegovy offers benefits over other approved treatments for weight loss, such as additional weight loss. OPDP further alleges that these claims imply benefits like emotional relief and “a solution to broader life challenges.” OPDP also alleges that the TV ad is misleading because it does not present the major statement using both audio and text simultaneously (dual modality).

Untitled Letter to Sobi, Inc. (February 6, 2026)

OPDP’s untitled letter to Sobi, Inc. (Sobi) alleges that a DTC broadcast advertisement (TV ad) misbrands Vonjo capsules by making false or misleading representations about the drug’s risks and benefits. Vonjo is indicated for the treatment of “adults with certain types of myelofibrosis who have a platelet count below 50 x 10⁹/L.”

OPDP states that the TV ad includes claims such as “turn the page with VONJO,” along with visual presentations such as an elderly man walking his dog in the park, eating ice cream, and dancing with his dog. OPDP alleges that the claims and presentations are misleading because they imply patients can improve emotional and social functioning; however, the underlying data did not show a statistically significant improvement of patient symptoms compared to existing treatments.

Additionally, OPDP alleges that the ad is misleading because it states that it is for use in adults with “low” platelet counts, but it does not specify what “low” means. OPDP also states that the TV ad discusses the benefits of the drug, but it fails to mention important risk information such as severe and/or life-threatening side effects. Lastly, OPDP alleges that “the attention-grabbing visuals,” multiple scene changes, and music during the major statement interfere with the viewer’s understanding of the major statement.

Untitled Letter to Johnson & Johnson International, Inc. (February 6, 2026)

OPDP’s untitled letter to Johnson & Johnson International, Inc. (Johnson & Johnson) alleges that a DTC broadcast advertisement (TV ad) misbrands Tremfya by making false or misleading statements.

The letter cites the following claims in the TV ad:

  • “Many people experienced remission at 1 and even 2 years”
  • “~1 out of 2 patients were in clinical remission at 1 year and at 2 years”
  • “1 out of 3 patients achieved endoscopic remission at one year”

OPDP alleges that these claims are misleading because the cited figures come from a study with patients who first responded to treatment after 12 weeks. OPDP states that a substantial portion of patients (about 38–39%) did not respond initially and therefore were never eligible for the maintenance study where the remission rates were measured, making the overall likelihood of long-term remission materially lower than the ad suggests. Further, OPDP states that the two-year claims are misleading because the claims imply the one- and two-year studies were of the same patient group, but the two-year study was conducted on patients who responded positively to the one-year study.

OPDP also takes issue with claims in the TV ad that state “[s]ome saw one hundred percent visible healing of their intestinal lining,” and “[h]ealing is possible with Tremfya.” OPDP alleges that these claims are misleading because they overstate the efficacy of Tremfya by implying it has a “curative” effect, when the data is not certain. OPDP acknowledges that the ad includes a disclaimer that “[v]isually assessed areas may not represent remission of the entire colon lining. Individual results may vary,” but OPDP states that this statement does not mitigate the misleading implications of the claims.

Lastly, OPDP alleges that the ad is misleading because it excludes material risk information; for example, the major statement does not state that Tremfya may lower the immune system’s ability to fight infections and may increase the risk of infections. 

Untitled Letter to Novo Nordisk Inc. re OZEMPIC (February 26, 2026)

OPDP’s untitled letter to Novo Nordisk Inc. (Novo Nordisk) alleges that a DTC video misbrands Ozempic (semaglutide) by making false or misleading representations about the drug’s efficacy.

OPDP summarizes the presentation and audio of the video, explaining that two actors, one representing Ozempic and one representing “other GLP-1s [(Glucagon-like peptide-1)] for type 2 diabetes” listen to a character who presents the benefits of Ozempic. Among other claims, the character states that “for adults with type 2 diabetes, Ozempic is the GLP-1 with the most FDA-approved uses.” OPDP alleges that this claim is misleading because it implies that all type 2 diabetes patients qualify for every Ozempic indication, when in fact certain indications require additional concurrent conditions. Specifically, type 2 diabetes patients must also have “established cardiovascular disease” or “chronic kidney disease” to qualify for those indications.

While the complete FDA-approved indications appear in on-screen text after the audio claims, OPDP alleges that displaying this information does not adequately counteract the misleading impression conveyed by the audio claims.

OPDP also alleges the video misleadingly positions Ozempic as superior to “other GLP-1s” for type 2 diabetes. OPDP points to claims such as “I see you don’t have as many FDA-approved uses as Ozempic” and “There’s Only One Ozempic,” along with a comedic scene where the “other GLP-1s” character responds with a bird-calling sound, which OPDP states reinforces the superiority claim by implying “other GLP-1s” do not merit serious consideration. Additionally, the Ozempic character is wearing a bright shirt while the “other GLP-1s” character is wearing a “dull, gray” shirt, further implying Ozempic’s superiority and positivity. OPDP states that in fact, the available data does not establish Ozempic’s superiority over “other GLP-1s.”

Additionally, OPDP alleges that the video fails to communicate to viewers that important risk information follows the presentation, and instead the video shows the Ozempic logo and plays music signaling the end of the video. OPDP acknowledges that there is a statement instructing viewers to see prescribing information; nevertheless, according to OPDP, this is not adequate to mitigate the misleading impact.

CDER Compounding Warning Letters

CDER released over 30 letters in early March alleging that the recipients made false or misleading claims on their websites regarding compounded drug products purporting to contain semaglutide and tirzepatide. FDA issued a press release announcing these letters as a second wave of a crackdown initially launched in September 2025. The warning letters focus primarily on allegations of “implying sameness with FDA-approved products and obscuring product sourcing by advertising drug products branded with the telehealth firm’s name or trademark without qualification, implying they are the compounder.” FDA notes that compounded drugs are not FDA-approved, meaning the agency has not reviewed their safety, effectiveness, or quality.

Like the September batch of letters, these warning letters differ from standard warning letters to pharmaceutical companies in content and form. For example, the letters generally state that the determinations are those of FDA, as opposed to those OPDP or APLB, and they are signed by the CDER or CBER Director, rather than an OPDP or APLB official. Additionally, the letters state that “FDA requests [Company] take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above.” This language is somewhat different from prior letters, which stated, in the case of OPDP, that “OPDP requests that [Company] cease any violations of the FD&C Act” and did not include language on “immediate action.”

Advertising and Promotional Labeling Branch (APLB)

Four Untitled Letters Regarding Single-Arm Studies

On March 9, 2026, APLB posted four untitled letters relating to the advertising and promotion of biologics. The letters all address biologics (or in some cases, a subset of the product’s indications) that were approved under FDA’s accelerated approval process, and APLB alleges in each case that the promotional material misleadingly presents overall survival benefits based on a single-arm study. The accelerated approval process measures intermediate clinical endpoints that are likely to predict clinical benefit. Sponsors of drugs approved under this pathway must conduct a confirmatory trial to confirm the clinical benefit of the drug.

Untitled Letter to Iovance Biotherapeutics (March 9, 2026)

APLB’s untitled letter to Iovance Biotherapeutics (Iovance) alleges that multiple promotional materials for Amtagvi make false or misleading claims about Amtagvi’s benefits. APLB cites public health concerns because the materials allegedly promote Amtagvi as more effective than has been demonstrated in clinical trials. APLB alleges that Amtagvi’s promotional materials imply it provides overall survival benefits. For example, the headline of a promotional material states that “19.7% of patients were alive at 5-year follow-up.”  APLB alleges that this claim is misleading because the single-arm study design, which lacked a comparator group, makes it impossible to determine whether observed survival effects are attributable to the drug or other factors such as natural disease progression. APLB acknowledges that the materials include a statement that “[o]verall survival [OS] in this single-arm trial is descriptive and conclusions cannot be drawn”; nevertheless, according to APLB, this is not adequate to mitigate the misleading message.

Untitled Letter to Juno Therapeutics, Inc. (March 9, 2026)

Similar to the Iovance untitled letter, this letter raises allegations about misleading benefit presentation based on a single-arm study. APLB alleges that Breyanzi’s promotional material includes suggestions that it provides progression-free survival and overall survival benefits for certain indications, including headlines like “74% of patients survived with no signs of disease progression at 18,” and “Median OS of 33.6 months was observed in TRANSCEND CLL 004.”  APLB acknowledges that the materials contain multiple disclaimers regarding the limitations of a single-arm study and the fact that overall survival and progression-free survival were not statistically tested. It further acknowledges that the materials cite various references to support the claims but states that neither the disclaimers nor the references mitigate the message conveyed by the materials.

Untitled Letter to Novartis Pharmaceuticals Corporation (March 9, 2026)

Like the other APLB letters issued on March 9, 2026, this letter alleges that several of the promotional materials for Kymriah are false or misleading because they make claims regarding progression-free survival and overall survival, such as “[a]n estimated 50% of patients treated with KYMRIAH were progression free at 48 months,” and “[a]n estimated 79% of patients treated with KYMRIAH were still alive 48 months after infusion” based on single-arm trials. APLB similarly asserts that the disclaimers included in the materials were insufficient.

Untitled Letter to Kite Pharma, Inc. (March 9, 2026)

Similar to the other three letters, this letter alleges that several promotional materials for Tecartus are false or misleading because they make claims such as “60% alive at 30 months (OS rate KM estimate),” “53% progression-free at 2 years (95% CI: 39.9, 64.3),” and “15.5 months RFS [relapse-free survival] in patients who achieved CR/CRi (n=39 responders),” but are based on single-arm trials. Again, APLB comments that the multiple disclaimers and cited references do not mitigate the misleading impression created in the promotional materials. 

Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH)

Warning Letter to Diasol, Inc. (January 29, 2026)

CDRH’s warning letter to Diasol, Inc. (Diasol) arose out of a July-August 2025 inspection of the company. CDRH alleges that the inspection revealed that Diasol is manufacturing disinfectants for dialysate delivery systems and water purification systems used in hemodialysis in a way that exceeds the 510(k) clearance held by the company, and the systems are thus misbranded. Although the company has 510(k) clearance for a Citric Acid product used in sorbent regenerated dialysis to allow physicians to customize the dialysate, CDRH states that the cleared product is not meant to be used for disinfection of hemodialysis machines. Therefore, Diasol was required to submit a new 510(k) for solutions intended for cleaning and disinfecting hemodialysis machines.

Warning Letter to ExThera Medical Corporation (February 6, 2026)

CDRH’s warning letter to ExThera Medical Corporation (ExThera) arose out of a May-June 2025 Bioresearch Monitoring (BIMO) inspection of the company related to two clinical studies sponsored by ExThera involving the Seraph 100 Microbind Affinity Blood Filter and the Onco-Seraph 100. Among other violations, CDRH alleges that the company engaged in improper pre-approval promotion of the Seraph 100 Microbind Affinity Blood Filter and makes false and misleading statements about the status of the Seraph 100 Microbind Affinity Blood Filter, based on a review of ExThera’s website and public statements by company officials. The letter cites claims made in a podcast by ExThera’s chief medical officer such as:

  • “Look we have had people under an IRB . . . under compassionate use with long COVID get the filter . . . clinically, their brain fog has improved, their fatigue has improved, and so clinically we’re seeing real benefit.” 
  • “This device has been in over 2,500 patients now, it’s very safe. It’s as safe as a dialysis procedure. So when you have a nice safety profile, you can move from the sickest patients in the intensive care unit which is what we did for COVID, and now we’re moving into outpatients who have cancer, who have long COVID, chronic viremia, chronic Lyme, etc. . . . and can we help people to treat the disease of aging.”

CDRH also alleges that the company’s chief medical officer stated at a conference that the device is safe and approved in the United States to treat COVID-19, even though it has no FDA approval for any use.

The letter states that in 2024 FDA had requested, during interactive review of an Investigational Device Exemption supplement, that ExThera remove promotional claims of safety and effectiveness from the company’s labeling and website, and also issued an It Has Come to Our Attention (IHCTOA) letter stating that Quadrant Clinical Care was promoting the Seraph 100 device and stating it was FDA cleared for COVID and sepsis. CDRH acknowledges that the Quadrant Clinical Care website is now unavailable. ExThera responded to the IHCTOA letter acknowledging that the device is not approved by the FDA for any indication and stating its commitment to ensure its distributors market the devices accurately. CDRH states that the company’s website and other statements conflict with this response.

Additionally, CDRH alleges that the company’s website included a potentially misleading statement that “[t]he Seraph 100 safety profile is consistent with standard extracorporeal labeling,” despite not being approved in the United States. CDRH states that ExThera revised its webpage and took additional preventive and corrective actions, but those actions do not include plans to ensure that promotional materials for distributors do not include inappropriate safety and effectiveness claims.

Warning Letter to Longhorn Vaccines and Diagnostics LLC (February 26, 2026)

CDRH’s warning letter to Longhorn Vaccines and Diagnostics LLC (Longhorn) arose out of an October 2025 inspection of the company. CDRH states that the inspection revealed that Longhorn is marketing the PrimeStore® MTM (Molecular Transport Medium)—a device for stabilization, transportation, and inactivation of infectious washes and human samples —for use outside of its De Novo authorization. PrimeStore MTM was granted marketing authorization “for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA,” and “the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples.” CDRH alleges, however, that Longhorn’s website shows that PrimeStore MTM is intended for use with additional microorganisms and specimen types to improve detection in low copy samples beyond the authorized indications and to detect antimicrobial resistance genes. For example, the website lists organisms for which PrimeStore MTM is intended for stabilization and inactivation, including, among others, Crimean-Congo hemorrhagic fever virus, Eastern equine encephalitis virus, Ebola virus, and Mpox. The website also states that “[t]he USDA recently expanded its use of PrimeStore MTM beyond SARS-CoV-2 and African Swine Fever to facilitate the tracking and surveillance of the avian influenza strain that is infecting wild bird populations and US poultry flocks.” CDRH also points to statements on the company’s product brochure that the device can detect “[v]iruses,” “[p]arasites,” “[b]acteria,” “[f]ungi,” and “AMR [g]enes,” and “[t]he device can be used for molecular testing and sequencing of blood, plasma, respiratory samples, urine, tissues and stool in human, animal, avian, plant and environmental forensics.”

CDRH states that these major changes to the intended use of the PrimeStore MTM could affect the safety and effectiveness of the device, cause inaccurate results, and pose safety risk to the user handling the clinical specimens, and therefore require new clearance or approval.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device practice.

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