Tag Archives: FDA

ATTD 2026 Key Press Releases (March 13)

On the third day of ATTD 2026, four cardiometabolic-related news items have been observed from Insulet, TIXiMED, Biocon, and Sana Biotechnology. Below, FENIX provides highlights and insights into the respective news items.

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FDA Issues Warning Letters for Misleading Pharmaceutical Advertising; Veru Initiates Enobosarm Ph2b PLATEAU Study; Vanda Initiates Tradipitant Ph3 Study

Three cardiometabolic-related news items have been observed: FDA issued warning letters for illegal marketing of compounded GLP-1RAs (view press release; view letters) and warned Novo over Ozempic ad (view article; view letter); Veru initiated the Ph2b PLATEAU study of enobosarm (selective androgen receptor modulator) for obesity (view CT.gov record); and Vanda Pharmaceuticals initiated the Ph3 tradipitant trial for the treatment of nausea and vomiting induced by GLP-1RA use (view CT.gov record).

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FDA Approves Biocon’s Generic Saxenda; Novo Partners for Oral Peptide Development; Medtronic Launches MiniMed Go in EU; Bloom Doses First Patient in Ph1 Obesity Trial; BreezeBio Raises $60M in Series B; Verdiva Completes Ph2b Obesity Enrollment; MHRA Raids Illegal Manufacturing Facilities in UK

A series of cardiometabolic-related news items has been observed from Biocon, Novo Nordisk, Medtronic, Bloom Science, Verdiva Bio, and MHRA. Below, FENIX provides highlights and insights for the respective news items.

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Novo Reduces Semaglutide WAC Prices; Pfizer To Commercialize Ecnoglutide in China; Novo Ph2 GGG data; AbbVie Builds Out Obesity Manufacturing; Fortress Sells PRV; Alveus Closes $197M Series A; Beta Bionics FDA Warning Letter; Hims & Hers Q4 ’25 Earnings

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Sciwind Biosciences/Pfizer, AbbVie, Fortress Biotech, Alveus Therapeutics, Beta Bionics, and Hims & Hers. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Retatrutide Risk Mitigation; Medtronic CY Q4 ’25 Earnings; 7.2mg Wegovy EU Approval; Lilly Targets India for Manufacturing Hub; EC Approval of Myqorzo; Esperion and Alkem Reach Generic BA Agreement

A series of cardiometabolic-related news items has been observed from Lilly, Medtronic, Novo Nordisk, Cytokinetics, and Esperion Therapeutics. Below, FENIX provides highlights and insights for the respective news items.

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Novo Super Bowl Ad; FDA Takes Stance on Compounding; Arrowhead Q4 ’25 Earnings

Three cardiometabolic-related new items have been observed: Novo Nordisk published its Wegovy Pill Super Bowl LX commercial (view press release); Marty Makary took a stance against compounders on X (view article; view post); and Arrowhead Pharmaceuticals hosted its Q4 ’25 earnings call (view press release). Additionally, TrumpRx (view here) has been officially launched, and FENIX will conduct an in-depth analysis early next week. Below, FENIX provides highlights and insights for the respective news items.

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Hims Launches Compounded Sema Pill; Novo London, AbbVie, GSK, and Novartis Q4 ’25 Earnings; Stelo Smart Meal Logging Updates; Abbott FDA Warning Letter and Class I Recall; Rare Pediatric PRV Program Reauthorized; Sciwind Ph3 OSA Study

A series of cardiometabolic-related news items has been observed from Hims & Hers, Novo Nordisk, AbbVie, GSK, Novartis, Dexcom, Abbott, the White House, and Sciwind Biosciences. Below, FENIX provides highlights and insights for the respective news items.

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