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FDA’s vaccines chief to depart in April – Prasad exits
Vinay Prasad will leave his role as director of the FDA’s Center for Biologics Evaluation and Research at the end of April, the agency confirmed in multiple reports. Prasad’s tenure included...
FDA doubles down on sham-control for uniQure’s Huntington’s gene therapy
A senior FDA official defended the agency’s reviewers and insisted uniQure must conduct a randomized sham‑controlled trial for AMT‑130, rejecting the company’s claims that the requirement was...
Servier to buy Day One for $2.5B – gains pediatric glioma asset
Servier signed a definitive agreement to acquire Day One Biopharmaceuticals for approximately $2.5 billion in cash, giving the French drugmaker access to Ojemda (tovorafenib), an FDA‑approved...
Petrelintide underwhelms investors – amylin rival trails Lilly’s GLP-1s
Phase 2 data for petrelintide, Roche‑partnered and developed by Zealand Pharma, showed mean placebo‑corrected weight loss of about 9% (10.7% absolute) at 42 weeks—below analyst expectations and...
FDA fast‑tracks J&J myeloma combo under national priority pilot
The FDA granted rapid approval to Johnson & Johnson’s Tecvayli plus Darzalex regimen for previously treated multiple myeloma under the Commissioner’s National Priority Voucher pilot, completing...
Alnylam pays Tenaya to mine up to 15 genetic cardio targets — deal tops $1B
Alnylam and Tenaya Therapeutics entered a research collaboration in which Tenaya will deliver up to 15 novel genetic targets for cardiovascular disease; Alnylam paid $10 million up front and the...
Ketone metabolite BHB sharpens CAR‑T potency in preclinical work; human trials launched
Researchers at the Arc Institute and Stanford reported that supplementation with β‑hydroxybutyrate (BHB) enhanced metabolic fitness and antitumor activity of CAR‑T cells in mouse models, and human...
FDA places partial hold on PepGen’s DM1 Phase 2 trial after re‑examining preclinical data
The FDA put a partial clinical hold on PepGen’s Freedom2‑DM1 Phase 2 study, citing concerns about previously submitted preclinical pharmacology and toxicology data in mice; the agency said the...
Illumina expands Alliance for Genomic Discovery with 50,000 proteomes
Illumina announced it will add 50,000 genomes paired with proteomic data to the Alliance for Genomic Discovery (AGD), broadening the alliance’s dataset and enabling integrated...
Perimeter wins FDA approval for Claire: AI‑guided margin imaging for breast conservation
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑powered wide‑field optical coherence tomography (OCT) device that provides surgeons with real‑time, high‑resolution...
Servier expands rare-cancer push: to buy Day One for $2.5B
Servier announced a definitive agreement to acquire Day One Biopharmaceuticals for roughly $2.5 billion, securing the pediatric glioma drug Ojemda and multiple investigational oncology programs....
FDA doubles down: demands sham-controlled trial for uniQure’s Huntington’s gene therapy
A senior FDA official publicly defended the agency’s reviewers and reiterated that uniQure must conduct a randomized sham‑controlled study to support approval of AMT‑130, its intracranial gene...
FDA accelerates Tecvayli-Darzalex approval: national priority pathway used
The FDA granted rapid approval to Johnson & Johnson’s Tecvayli paired with Darzalex Faspro for early relapsed/refractory multiple myeloma using the agency’s Commissioner’s National Priority...
Roche-Zealand amylin misses Lilly bar: phase‑2 efficacy disappoints
Roche and Zealand Pharma reported Phase 2 results for petrelintide showing mean weight loss of 10.7% (9.0% placebo‑adjusted) at 42 weeks and a favorable tolerability profile, but the efficacy...
FDA halts PepGen US Phase 2 over preclinical safety questions
The FDA placed a partial clinical hold on PepGen’s Freedom2‑DM1 Phase 2 trial after reviewers flagged preclinical pharmacology and toxicology findings — notably blood-pressure drops in mice —...
Alnylam pays Tenaya for heart‑disease genetics: up to $1.13B pact
Alnylam Pharmaceuticals and Tenaya Therapeutics struck a research collaboration in which Tenaya will deliver up to 15 novel genetic targets for cardiovascular disease discovery. Alnylam committed...
BillionToOne doubles revenue — raises full‑year guidance and inks UHC contract
Molecular diagnostics company BillionToOne reported Q4 revenue of $96.1 million, more than double year‑ago sales, and raised full‑year 2026 guidance to $430–$445 million. The company said it will...
Kestrel clears IND for oral pan‑KRAS inhibitor — first‑in‑human trial due
Kestrel Therapeutics secured FDA clearance to begin clinical testing of KST‑6051, an oral pan‑KRAS small‑molecule inhibitor targeting KRAS‑driven cancers. The company plans to open a...
UCLA engineers CAR‑T to breach solid‑tumor defenses
Researchers at UCLA unveiled a next‑generation CAR‑T platform engineered to overcome the immunosuppressive microenvironment of solid tumors. The preclinical work describes design features intended...
Gene therapy cuts seizures in Dravet: zorevunersen shows large reductions
A clinical program led by University College London and Great Ormond Street Hospital reported that zorevunersen, an investigational gene‑regulation therapy for Dravet syndrome, produced dramatic...