Tag Archives: EMA

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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Kailera Files IPO; Diamyd Data Disappoints; Insilico and Lilly Partner for AI Drug Discovery; EMA Approves Bayer’s Kerendia for HFpEF; Gan & Lee QW Insulin; Roche Ph1 CAD Study; Lilly Ph3 TOGETHER-PsA Results

A series of cardiometabolic-related news items has been observed from Kailera Therapeutics, Diamyd Medical, Insilico, Bayer, Gan & Lee Pharmaceuticals, Roche, and Lilly. Below, FENIX provides highlights and insights for 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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Structure Q4 ’25 Earnings; February CHMP Meeting Highlights

Two cardiometabolic-related news items have been observed: Structure released its Q4 ’25 earnings report (press release), and the CHMP highlights for this month’s meeting (February 23-26) have been released (view highlights). 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’s Wegovy Pill Off to Quick Start; New Ph3b Retatrutide Study; Lilly Launches Obesity Campaign; Biomed Initiates Two Ph3 Quadruple Agonist Trials; Alveus Advances Obesity Asset; Afrezza Label Update; January CHMP Agenda

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Lilly, Biomed Industries, Alveus Therapeutics, MannKind, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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Pfizer Acquires Oral GLP-1RA; FDA Grants AI Drug Development Tool in MASH; Lilly Discontinues Tempo; Novo Completes Akero Acquisition; Regeneron Registers siRNA Ph2 Study in DKD; December CHMP Agenda

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

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Novo Elects New Board; Positive Tzield CHMP Opinion

Two cardiometabolic-related news items have been observed: Novo Nordisk hosted its extraordinary general meeting and elected a new board (view press release); and Sanofi’s Tzield received a positive recommendation from CHMP (view press release). Below, FENIX provides highlights and insights for the respective news items.

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