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.
Prime Medicine shares jumped in after-hours trading after the FDA cleared PM647 for first-in-human testing, moving a one-time gene-editing therapy for alpha-1 antitrypsin deficiency from promising animal data into the much harder test of clinical development.
Merck & Co.’s remigromig matched ranibizumab on vision improvement in a pivotal diabetic macular edema trial, validating a novel Wnt-targeting approach while higher rates of proliferative diabetic retinopathy and vitreous hemorrhage leave an important safety question unresolved.
aTyr Pharma gains FDA alignment for a new efzofitimod Phase 3 trial in pulmonary sarcoidosis after the earlier EFZO-FIT endpoint miss.
Kyverna’s miv-cel sustains mobility gains and keeps 92% of SPS patients off chronic immunotherapy at one year as its FDA filing advances.
European regulators have approved AstraZeneca’s Trixeo Aerosphere for uncontrolled asthma from age 12 regardless of recent exacerbation history, potentially widening a respiratory franchise that generated $699 million in first-half 2026 sales.
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.
Compass Therapeutics shares plunged to a two-year low after the FDA recommended another survival trial before a tovecimig filing, creating a high-stakes disagreement over whether strong tumor-response and progression-free survival results are enough to support an approval application in advanced biliary tract cancer.
The European Commission has approved Rinvoq for active polyarticular juvenile idiopathic arthritis in children aged two and older, adding another patient population to AbbVie’s rapidly growing immunology franchise and introducing a weight-based oral solution for younger patients.
Roche’s sefaxersen hits its Phase III IgAN endpoint with significant proteinuria reduction. See what the result means for regulators and competitors.