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FDA clears Nereus: first new motion‑sickness drug in four decades
The U.S. Food and Drug Administration approved Nereus (tradipitant) from Vanda Pharmaceuticals based on three pivotal studies, including two phase III real‑world trials with subjects on boats. The...
FDA issues CRL for relacorilant – Corcept pivots to ovarian cancer
The U.S. FDA issued a complete response letter (CRL) to Corcept Therapeutics for relacorilant in hypertension secondary to hypercortisolism (Cushing syndrome), citing insufficient evidence of...
FDA grants priority review for AXS‑05 – Alzheimer’s agitation on an expedited clock
The FDA accepted and granted priority review to Axsome Therapeutics’ supplemental NDA for AXS‑05 to treat agitation in Alzheimer’s disease, setting a PDUFA target date of April 30. The agency’s...
Engineered viral platform edits macrophage RNA in vivo – sepsis therapeutic advance
Researchers published a bioengineered viral system in Nature Communications that enables targeted RNA editing in macrophages in vivo using chemogenetic control. The platform demonstrated editing...
Dietary methionine restriction reverses kidney fibrosis – epigenetic mechanism shown
A Nature Communications study led by Liu and colleagues found that dietary methionine restriction reversed kidney fibrosis in preclinical models through epigenetic remodeling. The investigators...
AAV9 'silence‑and‑replace' gene therapy prevents HSP in models
Researchers from Drexel University and UMass Chan published a 'silence‑and‑replace' AAV9 gene‑therapy strategy that prevented hereditary spastic paraplegia (HSP) symptoms in preclinical models,...
Henlius wins NMPA acceptance for three solid‑tumor INDs
Shanghai Henlius Biotech announced that China’s National Medical Products Administration accepted investigational new drug (IND) applications for three differentiated solid‑tumor candidates. The...
NIH agrees to re‑evaluate stalled grants after court challenge
The National Institutes of Health agreed to review hundreds of grant applications that had been paused under new diversity‑related directives after a legal challenge. Under the court‑overseen...
BioAtla and GATC form $40M SPV to advance ozuriftamab vedotin into registrational trial
BioAtla and GATC Health announced a $40 million special purpose vehicle to finance ozuriftamab vedotin (Oz‑V), a CAB‑ROR2 antibody‑drug conjugate, into a registrational Phase 3 study for...
Sanofi acquires Dynavax assets: adds HBV vaccine and shingles candidate
Sanofi expanded its vaccine portfolio through a deal that added Dynavax’s hepatitis B vaccine and a shingles candidate, according to a deals report. The transaction transfers vaccine assets and...
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...