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FDA’s vaccines and biologics chief to leave in April — second exit
Vinay Prasad will depart his role overseeing vaccines and biologics at the U.S. Food and Drug Administration at the end of April, ending a tumultuous tenure marked by several high‑profile...
Servier pays $2.5B for Day One — gains pediatric glioma drug
Servier agreed to acquire Day One Biopharmaceuticals for approximately $2.5 billion in cash, taking ownership of Day One’s marketed pediatric glioma therapy Ojemda (tovorafenib) and its broader...
FDA doubles down on sham‑control demand — uniQure dispute escalates
The FDA reiterated it will require a sham‑controlled randomized trial for uniQure’s AMT‑130 gene‑therapy program in Huntington’s disease, despite objections from the company about the ethics and...
FDA fast‑tracks Tecvayli–Darzalex combo: national‑priority clearance
The FDA granted rapid approval to Johnson & Johnson’s Tecvayli in combination with Darzalex Faspro for previously treated multiple myeloma under the agency’s Commissioner’s National Priority...
Perimeter’s Claire imaging device wins FDA premarket approval — intraoperative AI
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, its AI‑assisted wide‑field optical coherence tomography device designed to image surgical margins during breast‑conserving...
CAR‑astrocytes remove amyloid in mice — single‑dose proof of concept
Researchers at Washington University reported in Science that astrocytes engineered to express chimeric antigen receptors (CAR‑As) can target and clear amyloid‑β deposits in mouse models of...
Kestrel’s pan‑KRAS oral inhibitor cleared for IND — FIH trial to start
Kestrel Therapeutics received FDA investigational new drug clearance for KST‑6051, an oral pan‑KRAS inhibitor aimed at KRAS‑driven cancers, enabling a first‑in‑human phase I (FALCON) trial slated...
Study maps HIV‑1 lenacapavir resistance pathways — surveillance implications
A Nature Communications study traced recurrent and unique evolutionary routes by which HIV‑1 develops resistance to lenacapavir, a long‑acting capsid inhibitor. The research identified specific...
Japan clears first iPSC‑derived therapy for Parkinson’s — regulatory milestone
Japanese regulators approved the first therapy derived from induced pluripotent stem cells (iPSCs) for Parkinson’s disease, marking the world’s first authorization of an iPSC‑based clinical...
Scalable sample hashing boosts single‑cell multiomics for clinical samples
A new workflow introduces low‑cost, scalable sample hashing compatible with single‑cell multiomic platforms, enabling high‑throughput multiplexing of limited clinical specimens. The method builds...
FDA’s Vinay Prasad to depart in April — Replacement unclear
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will leave the agency at the end of April, the agency confirmed. Prasad’s tenure was marked by a string of...
Servier buys Day One for $2.5B — Gains pediatric glioma franchise
France’s Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion in cash, giving Servier ownership of Ojemda (tovorafenib), an FDA‑approved therapy for pediatric low‑grade...
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...