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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...
Servier shells out $2.5B for Day One – picks up pediatric glioma drug
Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion in cash, buying the company’s marketed pediatric glioma therapy Ojemda (tovorafenib) and its development-stage...
Prasad exits FDA in April — tenure marked by high‑profile clashes
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), will leave the agency at the end of April after a contentious tenure characterized by stringent reviews and...
FDA doubles down: uniQure told to run sham‑controlled Huntington’s trial
The FDA told uniQure that a sham‑controlled randomized trial is required for its surgically delivered gene therapy AMT‑130 for Huntington’s disease, with an unnamed senior official clarifying that...
Roche/Zealand amylin falls short — petrelintide’s weight loss underwhelms
Mid‑stage results for petrelintide, an amylin analog developed by Zealand with Roche, produced placebo‑adjusted weight loss of about 9.0% (10.7% mean reduction vs 1.7% placebo) at 42 weeks—below...
FDA greenlights J&J Tecvayli‑Darzalex combo under priority pathway — approval comes fast
The FDA approved Johnson & Johnson’s Tecvayli plus Darzalex Faspro combination for previously treated multiple myeloma and converted Tecvayli’s accelerated monotherapy approval to full approval...
Japan clears first iPSC‑derived therapy for Parkinson’s — regulatory milestone for regenerative medicine
Japan’s regulator approved the world’s first induced pluripotent stem cell (iPSC)‑derived therapy for Parkinson’s disease, marking a regulatory first for iPSC‑based regenerative treatments and...
Illumina expands alliance dataset — adds 50,000 genomes with paired proteomics
Illumina announced an expansion of the Alliance for Genomic Discovery dataset to include 50,000 additional genomes with paired proteomic data, generated using Illumina’s Protein Prep assay in...
Alnylam inks cardio pact with Tenaya — $10M upfront, $1.13B potential
Alnylam signed a collaboration with Tenaya Therapeutics to access up to 15 novel genetic targets for cardiovascular disease discovery. The deal includes $10 million up front and up to $1.13...
Kestrel wins IND for oral pan‑KRAS inhibitor KST‑6051 — first‑in‑human trial imminent
Kestrel Therapeutics secured FDA clearance for an IND to begin a first‑in‑human Phase I trial of KST‑6051, an oral pan‑KRAS inhibitor targeting KRAS‑driven cancers. The company plans to initiate...
Perimeter wins FDA clearance for Claire — AI‑powered margin imaging for breast surgery
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, its wide‑field optical coherence tomography device integrated with AI to image excised tissue margins during...
Servier buys Day One for $2.5B — Gains pediatric glioma drug and pipeline
Servier agreed to acquire Day One Biopharmaceuticals for about $2.5 billion in cash, gaining marketed pediatric glioma therapy Ojemda (tovorafenib) and a pipeline of oncology programs. The...
FDA vaccine and biologics chief Vinay Prasad to leave at month end — Agency transition underway
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), will depart the agency at the end of April, FDA and news reports confirmed. Prasad’s tenure drew repeated...