FDA cleared two zanidatamab regimens on 25 August, including a bispecific-plus-PD-1 combination for all HER2+ advanced GEA regardless of PD-L1 status, on Phase 3 data already in NEJM.
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A 25 August Nature Biomedical Engineering paper shows malignant synapses concentrated at the GBM–brain interface, then tests an intracavitary TrkB-silencing hydrogel that more than doubled median survival in a mouse resection model.
FDA approved garetosmab on 19 August as the first FOP drug shown, in a placebo-controlled trial, to cut both new heterotopic-ossification lesions (by ≥90%) and clinician-assessed flare-ups.
On 18 August the D.C. Circuit let Teva’s challenge to CMS’s “bona fide marketing” generic test go forward, while upholding CMS’s decision to treat Austedo and Austedo XR as one drug. That is not a repeal. It is a seam.
Amylyx’s Phase 3 LUCIDITY hit on 18 August: avexitide cut Level 2/3 hypoglycemia 55% versus placebo in post-bariatric hypoglycemia — a first-in-class blocker of the same receptor the industry has spent years agonizing.
Jazz agreed on 10 August to buy Actio Biosciences for $820 million cash plus $500 million in milestones, spinning out everything that is not ABS-1230, to bolt a precision ion-channel drug onto Epidiolex.
Two earnings prints in 48 hours showed the obesity market splitting: Lilly raised the ceiling; Novo raised guidance into a decline.