Tag Archives: FDA

Lilly Launches Zepbound KwikPen; Allurion Gains FDA Approval; Eversense 365 Launches with twiist AID System; February CHMP Agenda

A series of cardiometabolic-related news items has been observed from Lilly, Allurion Therapeutics, Sequel Med Tech/Senseonics, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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Beta Bionics and Insulet Q4 ’25 Earnings; Lilly Taltz+Zepbound PsO Combination Data; Zealand Ph1a Kv1.3 Inhibitor Topline Results

A series of cardiometabolic-related news items has been observed from Beta Bionics, Insulet, Lilly, and Zealand Pharma. Below, FENIX provides highlights and insights on 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 and Hims Compounding Saga Concludes?; Obesity Spotlighted in the Super Bowl; Lilly Registers ENLIGHTEN-6 Eloralintide Study; MannKind Initiates Afrezza New Onset T1DM Trial

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Hims & Hers, Super Bowl LX, Lilly, and MannKind. Below, FENIX provides highlights and insights on 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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Novo Initiates Two Cagrisema Formulation/Device Trials; Lilly Initiates Third Ph3 Eloralintide Trial; FDA Approves Zepbound Kwikpen; Roche Increases Investment for Obesity Manufacturing Site; Abbott Q4 ’25 Earnings; CORXEL Closes $287M Series D1 Funding; Sesame Partners with Novo for Wegovy Pill

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Lilly, Roche, Abbott, Corxel Pharmaceuticals, and Sesame. Below, FENIX provides highlights and insights for the respective news items.

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JPM 2026 Day 4: IVA, JNGHF, LXRX, BMEA, ESPR; FDA Delays CNPV Approvals

On the fourth and final day of JPM 2026, FENIX has provided coverage of presentations by Inventiva Pharma, Jiangsu Hengrui Pharmaceuticals, Lexicon Pharmaceuticals, Biomea Fusion, and Esperion. Separately, one CVRM-related news item has been observed: FDA has delayed CNPV approval of Tzield and orforglipron (view article). Below, FENIX provides highlights and insights from the JPM presentations as well as insight into the CNPV delays.

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Holiday Hangover: Novo Launches Wegovy Pill; Additional Companies Engage in MFN Deals; Pfizer Initiates Ph3 Obesity Program of MET097i; and More

Over the holiday period, a series of cardiometabolic news items were observed from Novo Nordisk, The White House, Pfizer, Cytokinetics, Resoundant, Sanofi, Skye Biosciences, MetaVia, Dexcom, Abbott, MannKind, BI/Rectify, Ascletis Pharma, Laekna Pharma, CMS, and Caliway Biopharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Lilly’s Ph3 ATTAIN-MAINTAIN Results; Orforglipron Filed; Novo Files Cagrisema and Receives FDA Warning Letter; Merck to Receive CNPV; SAB BIO Pivotal Ph2b T1DM Trial; Sagimet Enters Agreement for Resmetirom

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Merck, SAB Biotherapeutics, and Sagimet Biosciences. Below, FENIX provides highlights and insights for the respective news items, including what Sagimet could be thinking vs. Madrigal.

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