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FDA greenlights Vanda’s Nereus: first motion‑sickness drug in more than 40 years
The FDA approved Vanda Pharmaceuticals’ oral drug Nereus (tradipitant) for preventing vomiting due to motion sickness. The agency’s decision is based on three pivotal studies, including two phase...
FDA gives Axsome priority review: AXS‑05 for Alzheimer’s agitation gets April 30 PDUFA
The FDA accepted Axsome Therapeutics’ supplemental new drug application for AXS‑05 (Auvelity) to treat agitation in Alzheimer’s disease and granted priority review, setting an April 30 PDUFA date....
FDA delivers CRL to Corcept — relacorilant blocked for Cushing’s hypertension
The U.S. FDA issued a complete response letter to Corcept Therapeutics for relacorilant in the indication of hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional...
NIH to re‑evaluate paused grants: agency agrees to court‑ordered scientific review
The National Institutes of Health agreed to reassess hundreds of grant applications that had been paused after new administration directives limited funding for research involving diversity,...
FDA final BiMo guidance: agency declines to clarify on‑site access restrictions
The FDA released its final bioresearch monitoring (BiMo) guidance for clinical trial inspections but did not add concessions regarding on‑site access or the hazards of electronic access during...
Insilico caps year with Hong Kong IPO: AI drug developer lists in HK
Insilico Medicine completed a Hong Kong IPO late in the year, marking a notable public market debut for an AI‑driven drug discovery company. The offering bolsters Insilico’s capital base to...
FDA grants De Novo to HAI Solutions — QIKCAP cleared for UVC microbial reduction
The FDA granted De Novo classification to HAI Solutions for its QIKCAP System, a UVC device designed to reduce microbes on needleless IV connectors. The decision establishes a novel regulatory...
FDA clears Medtronic’s Hugo and CMR’s Versius Plus — new robotic systems enter US market
The U.S. FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system and CMR Surgical’s Versius Plus system for the U.S., expanding hospital options beyond the longstanding da Vinci...
China’s NMPA accepts Hutchmed’s fanregratinib NDA: priority review for FGFR therapy
China’s National Medical Products Administration accepted Hutchmed’s NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, and granted priority review....
BioAtla and GATC form $40M SPV to push Ozuriftamab into registrational Phase 3
BioAtla and GATC Health announced a $40 million special purpose vehicle to advance ozuriftamab vedotin (Oz‑V), a CAB‑ROR2‑ADC, into a registrational Phase 3 trial for second‑line and later...
FDA clears motion-sickness pill: Vanda wins first approval in 40 years
The U.S. Food and Drug Administration approved Vanda Pharmaceuticals’ oral drug Nereus (tradipitant), marking the first new pharmaceutical treatment for motion sickness in more than four decades....
FDA fast-tracks Axsome’s AXS-05: Priority review set for Alzheimer’s agitation
The FDA accepted Axsome Therapeutics’ supplemental new drug application for AXS-05 (Auvelity) to treat agitation in Alzheimer’s disease and granted the filing priority review, assigning an April...
FDA issues CRL for relacorilant... Corcept pivots to oncology
The U.S. Food and Drug Administration issued a complete response letter (CRL) to Corcept Therapeutics for relacorilant in the indication of hypertension secondary to hypercortisolism (Cushing...
Asia IPO wave: Insilico lists in Hong Kong; Shenzhen Edge prices $154M offering
Two high‑profile capital markets events closed 2025: Insilico Medicine completed a Hong Kong IPO, furthering the trend of AI‑driven drug developers tapping Asian markets, while Shenzhen Edge...
FDA clears two surgical robots — competition heats up for Intuitive
The U.S. FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system and CMR Surgical’s Versius Plus system for the U.S. market, introducing new commercial alternatives to Intuitive...
Viral RNA editors in macrophages: A new in vivo sepsis strategy
Researchers reported a bioengineered viral platform that delivers RNA‑editing machinery to macrophages in vivo, enabling targeted editing within the immune cells of living organisms as a...
BioAtla, GATC create $40M SPV: Oz‑V pushed into registrational Phase 3
BioAtla and GATC Health announced a special purpose vehicle (SPV) transaction worth $40 million to advance ozuriftamab vedotin (Oz‑V; CAB‑ROR2‑ADC) into a registrational Phase 3 study for...
NIH agrees to review paused grants: court settlement reopens applications
The National Institutes of Health agreed to review hundreds of grant applications that had been paused under administration directives restricting funding on diversity‑related research topics. The...
Judge halts 340B rebate pilot — implementation paused by court order
A federal judge in Maine issued a temporary restraining order blocking the Department of Health and Human Services' 340B Rebate Model Pilot Program that would have converted upfront 340B discounts...
2025 marks a breakthrough for in vivo gene therapies — clinical momentum and new AAV9 data
Multiple advances in 2025 signaled a turning point for in vivo gene therapies as delivery, targeting and clinical strategies matured. Industry reviews conclude the year saw meaningful progress...