Two rare-disease approvals landed ahead of their own clocks, the FDA launched a pilot explicitly designed to compress first-in-human timelines, and a $350 million IPO priced and opened without a pop — a week…
FDA approved imlunestrant plus abemaciclib for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, detected by an FDA-authorized test, after progression on at least one endocrine-therapy line. FDA simultaneously approved Guardant360 CDx…
FDA expanded Aqneursa, levacetylleucine, to treat ataxia in adults and children with ataxia-telangiectasia who weigh at least 15 kilograms. It is the first approved treatment for the neurologic manifestation of this rare ATM-deficiency disorder….
Bristol Myers Squibb discontinued the Phase I program for ORM-6151, also known as BMS-986497, after reviewing clinical data in AML and MDS. The CD33-targeted degrader-antibody conjugate carried a GSPT1 molecular-glue payload and was the…
EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending authorization of denecimig (Frehemgo) for routine prophylaxis of bleeding in patients of all ages with hemophilia A, with or without factor…
Novo Nordisk acquired three early-stage non-incretin obesity programs from Kallyope, including IND-ready peptide K-554, a follow-on small molecule against an undisclosed novel target, and a separate small-molecule receptor agonist. Financial terms and specific targets…
FDA approved Fayuvi, a one-time intravenous AAV9 gene therapy, for neurologic manifestations of mucopolysaccharidosis IIIA in pediatric patients with preserved neurodevelopmental function. The approval is the first U.S. treatment for Sanfilippo syndrome type A….
Xenon voluntarily paused enrollment of new participants in its Phase III major-depressive-disorder and bipolar-depression studies after reviewing neuropsychiatric adverse events. Existing randomized and open-label-extension participants remain on study, and the company expects the pause…
Bavarian Nordic appointed Tarja Stenvall president and chief executive officer effective October 15, 2026, succeeding Paul Chaplin. The company previously disclosed that Chaplin would leave for personal reasons connected with a family relocation to…
Electra Therapeutics priced an upsized initial public offering of 23,333,334 shares at $15 each for expected gross proceeds of approximately $350 million, before underwriting discounts and expenses. The financing is unusually large for a…
