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FDA shake-up: Vinay Prasad to exit at end of April
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will depart the agency at the end of April, capping a turbulent term marked by high-profile reversals and industry...
FDA doubles down — uniQure must run sham‑controlled Huntington trial
The FDA insisted this week that uniQure conduct a sham‑controlled randomized trial for AMT‑130, the company’s gene therapy for Huntington’s disease, defending reviewers’ request despite company...
Servier bets $2.5B on pediatric glioma — Day One buy seals rare‑cancer push
Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion in cash, a deal that gives the French pharma company Ojemda (tovorafenib) — an FDA‑approved therapy for pediatric...
Petrelintide underwhelms — Roche/Zealand readout misses investor marks
Roche and Zealand Pharma reported mid‑stage data for petrelintide showing about 10.7% mean placebo‑controlled weight loss at 42 weeks, short of investor expectations and materially below competing...
FDA fast‑tracks J&J myeloma combo — Tecvayli‑Darzalex cleared under priority pilot
The FDA granted speedy approval to the combination of Johnson & Johnson’s Tecvayli and Darzalex Faspro in previously treated multiple myeloma under the agency’s Commissioner’s National Priority...
Perimeter’s Claire wins FDA premarket approval — real‑time margin imaging cleared
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑enabled wide‑field optical coherence tomography device designed to detect cancer at excised breast margins in real...
IND advances: Kestrel’s pan‑KRAS oral candidate cleared — epigenetic immunoactivator also greenlighted
Kestrel Therapeutics received FDA investigational new drug clearance for KST‑6051, a novel oral pan‑KRAS inhibitor, enabling the FALCON first‑in‑human phase I trial to start by quarter end. The...
Biopharma cash returns: financings surge — Solid Biosciences raises $240M
Biopharma financings jumped 81% year‑over‑year in Jan–Feb 2026, signaling renewed investor appetite across the sector. Solid Biosciences closed a $240 million private placement to fund pipeline...
New neuro approaches: CAR‑astrocytes clear amyloid in mice; tanycytes tied to tau clearance
Researchers at Washington University engineered astrocytes expressing chimeric antigen receptors (CAR‑As) that reduced amyloid‑β plaque formation in Alzheimer’s mouse models after a single...
Targeting hidden resistance: new assays and AI models map antimicrobial escape
Two advances aim to sharpen antimicrobial resistance (AMR) detection and prediction. Ma and Kim introduced the dilution‑and‑delay (DnD) susceptibility assay in Nature Communications, a...
FDA’s embattled vaccine chief Prasad exits again — April departure
Vinay Prasad will leave the FDA at the end of April, marking a second departure after a tenure marked by high-profile reversals and industry clashes. Multiple outlets reported the move; STAT and...
Servier picks up Day One: $2.5B deal for pediatric glioma drug
Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion, securing Ojemda (tovorafenib), an FDA‑approved therapy for pediatric low‑grade glioma, and an early‑to‑late-stage...
FDA doubles down on uniQure — defends sham‑controlled trial demand
The FDA has publicly defended reviewers’ request for a sham‑controlled randomized study for uniQure’s AMT‑130 Huntington’s gene therapy, rejecting the company’s characterisation of the procedure...
Petrelintide underwhelms investors: Roche/Zealand readout misses expectations
Roche and Zealand Pharma reported Phase 2 ZUPREME‑1 results for amylin analogue petrelintide showing roughly 10.7% mean weight loss versus 1.7% for placebo — below investor expectations for a...
CAR‑astrocyte therapy: single injection prevents and clears amyloid in mice
Researchers at Washington University engineered astrocytes expressing chimeric antigen receptors (CAR‑As) that prevented amyloid‑β plaque formation when given prophylactically and reduced...
FDA greenlights Tecvayli‑Darzalex: swift approval under CNPV pilot
The FDA granted speedy approval to Johnson & Johnson’s Tecvayli (teclistamab) combined with Darzalex Faspro (daratumumab‑fatum) for previously treated multiple myeloma under the Commissioner’s...
Kestrel wins IND for pan‑KRAS oral inhibitor — FALCON trial set
Kestrel Therapeutics secured FDA IND clearance for KST‑6051, an oral pan‑KRAS inhibitor targeting KRAS‑driven cancers, and plans a first‑in‑human phase I FALCON study by the end of the first...
Perimeter’s Claire gets FDA PMA — real‑time margin imaging for breast surgery
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, its AI‑augmented wide‑field optical coherence tomography device designed to image excised breast margins intraoperatively....
Lonza agrees $2.2B sale of capsule and health‑ingredients business
Lonza reached a deal to sell its capsule and health ingredients unit to a UK‑based investment firm for $2.2 billion upfront as part of a portfolio simplification move. The sale follows...
Biopharma financings jump 81% in early 2026 — $16.78B raised
Biopharma companies raised $16.78 billion in public and private financings in January–February 2026, an 81% increase year‑over‑year, signaling renewed investor appetite for life‑science...