Tag Archives: FDA

FDA Leadership Pushes for Expedited Orforglipron Review; Novo and Cytokinetics Positive CHMP Opinions; Rezolute Misses Endpoints in Ph3 Study

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Rezolute, and Cytokinetics. 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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Insulet O5 Algorithm Updates; BioAge Ph1 NLRP3i Data

Two cardiometabolic-related news items have been observed: Insulet announced it received 510(k) clearance for updates to the O5 algorithm (view press release); and BioAge Labs announced topline Ph1 data of its NLRP3i (BGE-102) in development for obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly Cuts Zepbound Prices; Cagrisema Ph3 Pediatric Obesity Trial; Ascletis Selects Obesity Candidate; Altimmune Replaces CEO; Olazarsen Breakthrough Therapy Designation; New Ph3 Bofanglutide Study; Ikaria Registers Study for Obesity Asset Monotherapy and Combination with Tirzepatide

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Altimmune, Ionis Pharmaceuticals, Gan & Lee Pharmaceuticals, and Ikaria Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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Novo Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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Medtronic CY Q3 ‘25 Earnings; Vanda Obesity Adjunct Therapy Results; Lilly Registers Another Retatrutide Ph3 Study; FDA Approves Arrowhead’s REDEMPLO in FCS

A series of cardiometabolic-related news items has been observed from Medtronic, Vanda Pharmaceuticals, Lilly, and Arrowhead Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Novo and Pfizer Up Metsera Bids…Again; Novo/Lilly Strike MFN Deal; Lilly Ph2 Amylin Data; Viking Presents VK2735 Data at ObesityWeek; AstraZeneca Q3 ’25 Earnings

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

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Beta Bionics Q3 ’25 Earnings; Lilly Partners with Walmart & Invests in Oral Manufacturing; Tandem Integrates with Libre 3+; More Novo Leadership Changes

A series of cardiometabolic-related news items have been observed from Lilly, Beta Bionics, Tandem Diabetes Care, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.

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Rybelsus CVRR Approval; FDA Hands Out First CNPVs, Including Tzield; Novo Hires New SVP; Ascletis Ph2 ASC30 Trial Update; BI Appoints New Obesity and Liver Head

A series of cardiometabolic-related news items have been observed from Novo Nordisk, FDA, Sanofi, Ascletis Pharma, and Boehringer Ingelheim. Below, FENIX provides highlights and insights for the respective news items.

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Novo Cuts Cell Therapy R&D Division; FDA Accepts Afrezza Peds sBLA; Ascletis Selects Obesity Candidate; Lilly Initiates Ph2 Macupatide and Eloralintide Trial; October CHMP Agenda

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

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