Tag Archives: FDA

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

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.

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here