Tag Archives: FDA

Tzield Stage 3 T1DM Approval; Stelo Pediatric Label Expansion; Marc Breton Joins Tandem

Three cardiometabolic-related news items have been observed: FDA approved Tzield for pediatric Stage 3 T1DM (view press release), Dexcom received FDA clearance of Stelo for people ≥2 years of age (view approval), and Marc Breton joined Tandem Diabetes Care (view LinkedIn post). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Lilly Interim Heart-2 Results; Ionis Q6M sHTG Study; CNPV Program Future; Biosimilar Lantus Approval

A series of cardiometabolic-related news items has been observed from Lilly, Ionis, FDA, and Lannett. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Another FDA Official Fired; AZ’s Baxdrostat Approved for HTN; Dexcom Flex to Launch in Germany; May CHMP Agenda

A series of cardiometabolic-related news items has been observed from FDA, AstraZeneca, Dexcom, and EMA. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

ProRx FDA Warning Letter; Lilly Partners with UNICEF

Two cardiometabolic-related news items have been observed: FDA issued a warning letter to ProRx regarding GLP-1RA compounding (view FDA letter) and Lilly partnered with UNICEF (view press release). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Makary Resigns; Novo OASIS 4 Data; Altimmune Q1 ’26 Earnings; Lilly SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN Full Data; Insulet Initiates O6 vs. O5 Study

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

This content is for Read Less members only.

Already a member? Log in here

Cytokinetics Shares Aficamten Data; FDA Launches Pilot One-Day Inspectional Assessments

Two cardiometabolic-related news items have been observed: Cytokinetics presented additional aficamten data (view press release), and FDA launched pilot one-day inspectional assessments (view FDA news release). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Lilly, Viking, and Merck Q1 ’26 Earnings; FDA Semaglutide and Tirzepatide Compounding Exclusions

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

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here