Tag Archives: FDA

FDA Publishes Foundayo Letter of Approval; Novo Partners with OpenAI for AI Drug Development; Sana T1DM Collaboration; Corbus Doses Last Patient in Ph1 CB1 Study

A series of cardiometabolic-related news items has been observed from FDA/Lilly, Novo Nordisk, Sana Biotechnology, and Corbus Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Ex-Novo Exec Joins BI; MetaVia Doses First Patient in Final Part of Ph1 Obesity Study; LifeMD to Offer Foundayo; Modular Medical Receives FDA Clearance for Pump Patch; MiniMed Pump Recall

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Boehringer Ingelheim, MetaVia, LifeMD, Modular Medical, and FDA/MiniMed. Below, FENIX provides highlights and insights for the respective news items.

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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 Updates Compounding Policies; Skye Doses First Patient in Ph2 Expansion Study; Aspect Receives $79M in Funding

Three cardiometabolic-related news items have been observed: FDA updated its GLP-1RA compounding policies (view statement); Skye Bioscience dosed the first patient in Part C of the Ph2a CBeyond trial evaluating higher doses of nimacimab (view press release); and Aspect Biosystems received $79M in funding from the Canadian government (view press release). Below, FENIX provides highlights and insights on the respective news items.

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Novo Initiates Ph1 Oral ASCL5 Inhibitor Study for Obesity; FDA to Host Public Feedback Meeting on CNPV; March CHMP Agenda

Three cardiometabolic-related news items have been observed: Lexicon Pharmaceuticals and Novo Nordisk initiated a Ph1 obesity study of its oral ASCL5 inhibitor (view press release); FDA shared plans to host a public feedback meeting regarding the CNPV pilot program (view press release); and the CHMP agenda for this month’s meeting (March 23-26) has been released (view agenda). Below, FENIX provides highlights and insights for the respective news items.

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Retatrutide T2DM Data Continue to Impress; FDA Approves Novo’s High Dose Sema

Two cardiometabolic-related news items have been observed: Lilly shared positive topline data from its Ph3 TRANSCEND-T2D-1 study of retatrutide (view press release), and Novo Nordisk received FDA approval for its 7.2mg Wegovy (view press release). Below, FENIX provides highlights and insights on the respective news items, including a safety/efficacy analysis of how the TRANSCEND results position retatrutide relative to tirzepatide and cagrisema.

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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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