The FDA has approved Eli Lilly and Company’s Mounjaro to reduce cardiovascular death, heart attack and stroke risk in high-risk adults with type 2 diabetes, significantly broadening the clinical case for tirzepatide beyond glucose control and weight reduction.
Scholar Rock has removed the OAI-classified Catalent Indiana facility from apitegromab’s US filing, preserving its September 30 FDA target through an alternate manufacturer while withdrawing and preparing to resubmit the European application.
Scholar Rock shifts apitegromab’s FDA review to a second fill-finish site as its September 30 SMA decision date remains on track.
Verdiva Bio has begun Phase 1 testing of weekly oral amylin candidate VRB-103. See what the trial can prove and what remains uncertain.
See how Novellia’s GLP-1 registry could sharpen real-world evidence while facing tests on validation, bias, privacy and payer use.
Agios Pharmaceuticals, Inc. has decided not to advance tebapivat in sickle cell disease after a randomized Phase 2 trial involving 59 participants failed to establish the differentiated clinical profile required for further investment. The Nasdaq-listed rare-disease drug developer said the once-daily pyruvate kinase activator improved haemoglobin and markers of haemolysis, but the response pattern did
Discover how Evidation’s 165,000-person study reveals GLP-1 growth potential, access gaps and persistence risks shaping obesity care. Read more.
Read how Shantha Biologics’ Novo Nordisk cartridge fill-finish deal could reshape complex injectable manufacturing in India.
Find out how Pfizer’s berobenatide Phase 2b data could reshape monthly GLP-1 obesity treatment and late-stage trial strategy.
Generic semaglutide is cheaper, but access is now the real battleground. Phoenix and Raven are testing Canada’s GLP-1 telehealth future.