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Vanda wins FDA sign-off: first new motion-sickness pill in 40 years
The U.S. Food and Drug Administration approved Vanda Pharmaceuticals’ oral drug Nereus (tradipitant) for preventing vomiting due to motion sickness, based on three pivotal studies including two...
FDA grants priority review to Axsome’s AXS-05 for Alzheimer’s agitation
The U.S. FDA accepted Axsome Therapeutics’ supplemental new drug application for AXS-05 (Auvelity) to treat agitation in Alzheimer’s disease and granted it priority review, setting a PDUFA date of...
FDA issues CRL to Corcept — company pivots to oncology push
The FDA issued a complete response letter to Corcept Therapeutics for relacorilant in patients with hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional efficacy...
Engineered viruses edit macrophage RNA in vivo: new sepsis strategy
Researchers published a Nature Communications report demonstrating a bioengineered viral platform that edits RNA in macrophages in vivo to treat sepsis. The chemogenetic system enables...
Gene therapy momentum: 2025 breakthroughs and a SPAST-AAV9 win
Industry reviews flagged 2025 as a breakthrough year for in vivo gene therapies, noting progress on delivery, efficacy, and clinical translation. Supporting that narrative, a preclinical study...
ADC program pushed into registrational trial via $40M SPV – field still expanding
BioAtla and GATC Health announced a $40 million special purpose vehicle to advance ozuriftamab vedotin (Oz-V), a CAB-ROR2 antibody-drug conjugate, into a registrational Phase 3 study for...
Biotech IPOs land in Hong Kong: Insilico soars, Shenzhen Edge raises $154M
AI-driven drug developer Insilico Medicine completed a Hong Kong IPO, marking a milestone for AI-first biotech listings. Separately, Shenzhen Edge Medical raised HKD1.19 billion (about US$154...
Policy shock: NIH agrees to re-evaluate stalled grants; judge blocks 340B pilot
Federal court and administrative actions reshaped year‑end policy risk for life‑sciences research and hospital drug programs. The NIH agreed to resume scientific review of hundreds of grant...
China oncology and T-cell engager deals accelerate regional strategy
Global pharma activity in China intensified as AbbVie struck a deal with Zelgen Biopharmaceuticals for a DLL3-targeted clinical-stage T cell engager to develop in China, while Hutchmed secured...
FDA clears surgical robots and grants De Novo for UVC IV‑connector device
The FDA cleared two robotic surgical systems—Medtronic’s Hugo RAS and CMR Surgical’s Versius Plus—broadening hospital choices for robotic-assisted soft-tissue surgery. In parallel, HAI Solutions...
FDA clears motion-sickness drug — Vanda to launch Nereus
The U.S. Food and Drug Administration approved Vanda Pharmaceuticals’ oral drug Nereus (tradipitant), marking the first new pharmacologic treatment for motion sickness in over four decades. The...
FDA issues complete response letter — Corcept pivots to ovarian-cancer bid
The U.S. FDA issued a complete response letter (CRL) to Corcept Therapeutics for relacorilant in hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional evidence of...
FDA grants priority review: Axsome’s Auvelity for Alzheimer’s agitation gets April PDUFA
The FDA accepted Axsome Therapeutics’ supplemental NDA for AXS-05 (Auvelity) to treat agitation in Alzheimer’s disease and granted priority review, setting a PDUFA target of April 30. The...
FDA approves first TA-TMA therapy — Omeros’ Yartemlea cleared
The FDA approved Omeros Corporation’s Yartemlea (narsoplimab), the first approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA‑TMA). The approval...
Engineered viruses edit RNA in vivo — part of a breakthrough year for gene therapies
2025 capped a wave of advances for in vivo genetic medicines, and new experimental platforms extended that momentum into infectious‑disease and neurological arenas. The field review noted...
BioAtla and GATC form $40M SPV — Ozuriftamab moves toward registrational trial
BioAtla and GATC Health announced a $40 million special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz‑V; CAB‑ROR2‑ADC) into a Phase 3 registrational study for...
Shenzhen Edge prices $154M IPO; new surgical robots clear U.S. — competition heats up
Shenzhen Edge Medical priced an HKEX IPO to raise roughly US$154 million to expand its surgical robotics lineup and pursue international markets. The listing follows a busy year for med‑tech exits...
Insilico caps year with Hong Kong IPO — AI drug hunter goes public
Insilico Medicine completed a Hong Kong initial public offering, raising proceeds in a successful market debut for an AI‑driven drug‑discovery company. The offering underscores continued investor...
FDA grants De Novo for UVC QIKCAP — first clearance for microbial reduction on needleless IV connectors
The FDA granted De Novo classification to HAI Solutions’ QIKCAP System, a UVC device designed to reduce microbial contamination on needleless IV connectors. The decision marks a regulatory...
Regulatory turbulence: NIH to review stalled grants as 2025 ends
Industry observers called 2025 a year of regulatory turbulence in the U.S., with leadership changes, policy shifts and contested directives creating uncertainty for grantmakers, regulators and...