Tag Archives: warning letter

Foundayo Available in the US; FDA Issues Warning Letters for Unapproved GLP-1RAs; EMA Wegovy Label Update; Novo’s Lotte Bjerre Knudsen Departs; 23andMe Study Identifies Genetic Connection for GLP-1RA-Induced Weight Loss; Noom Partnership

A series of cardiometabolic-related news items has been observed by Lilly, FDA, Novo Nordisk, 23andMe, and Noom. Below, FENIX provides highlights and insights for 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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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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