Eli Lilly and Company has secured U.S. Food and Drug Administration approval for Onswik, its once-weekly basal insulin for adults with type 2 diabetes, bringing a second weekly insulin into the U.S. market and shifting the competitive question from regulatory feasibility to prescribing, access and real-world adoption.
Viking Therapeutics is seeking $400 million through stock and convertible-note offerings immediately after VK2735 obesity data sent its shares sharply higher, as the company accelerates Phase 3 development and explores monthly and every-other-week maintenance dosing.
European regulators have backed once-weekly Sogroya for children with idiopathic short stature, potentially giving Novo Nordisk the first EU-approved growth hormone specifically for the condition while expanding a rare-endocrine franchise beyond growth hormone deficiency.
Novo Nordisk has expanded its artificial-intelligence strategy through a collaboration with Anthropic that will test Claude Science in pharmaceutical R&D, adding another AI partner as the drugmaker seeks faster research productivity amid intensifying competitive pressure.
A new real-world study of sustained low-dose semaglutide and tirzepatide found measurable weight loss without escalation to standard maintenance doses, but researchers stress that prescription records do not prove intentional GLP-1 microdosing and the observational findings cannot establish cause and effect.
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.