Get the Daily Brief
Latest Biotech News
FDA doubles down on sham‑control for uniQure’s Huntington therapy — Dispute escalates
The FDA has defended its reviewers’ decision to require a sham‑controlled trial for uniQure’s AMT‑130 gene therapy for Huntington’s disease, saying the company must randomize patients to the...
Petrelintide underwhelms investors — Zealand shares tumble after mid‑stage readout
Roche and Zealand Pharma reported Phase II results for petrelintide, an amylin analog for obesity, that produced a mean 10.7% weight reduction at 42 weeks versus 1.7% for placebo — below investor...
CAR‑astrocytes clear amyloid in mice — Single dose halves plaque burden
Washington University researchers engineered astrocytes expressing chimeric antigen receptors (CAR‑As) that, when injected into mice, prevented amyloid‑β plaque formation if given before pathology...
Perimeter’s AI margin‑imaging Claire cleared by FDA — Point‑of‑care pathology for breast surgery
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑enabled wide‑field optical coherence tomography device that provides real‑time, high‑resolution imaging of excised...
Kestrel wins IND for oral pan‑KRAS inhibitor — First‑in‑human trial slated
Kestrel Therapeutics obtained FDA clearance of an Investigational New Drug application for KST‑6051, an oral pan‑KRAS small molecule intended for KRAS‑driven cancers. The company said it will...
FDA uses expedited pathway for J&J myeloma combo — Tecvayli‑Darzalex wins rapid clearance
The FDA granted expedited approval to Johnson & Johnson’s Tecvayli (teclistamab) combined with Darzalex Faspro (daratumumab) for previously treated multiple myeloma under the Commissioner’s...
Dilution‑and‑delay assay reveals hidden antibiotic resistance — High‑throughput tool emerges
Researchers Ma and Kim published a Nature Communications paper introducing the dilution‑and‑delay (DnD) susceptibility assay, a high‑resolution, high‑throughput method that uncovers bacterial...
Penn unveils sub‑millimeter solar‑powered robot — Microrobots aimed at biomedical tasks
Researchers at the University of Pennsylvania built what they describe as a sub‑millimeter robot equipped with sensors, a motor and an onboard computer, powered by microscopic solar cells. The...
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...