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FDA greenlights Nereus: Vanda lands first motion‑sickness drug in 40 years
The U.S. Food and Drug Administration approved Nereus (tradipitant), Vanda Pharmaceuticals’ oral neurokinin‑1 receptor agent, marking the first new prescription treatment for motion sickness in...
FDA gives priority review to AXS‑05 – Axsome targets 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 priority review, setting a PDUFA goal date...
FDA issues CRL to Corcept – relacorilant setback in Cushing, pivot to ovarian cancer
The FDA issued a complete response letter for Corcept Therapeutics’ relacorilant in hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional evidence of efficacy. The...
AbbVie inks DLL3 T‑cell engager deal in China – Zelgen supplies clinical‑stage asset
AbbVie struck a licensing and development arrangement with Zelgen Biopharmaceuticals for a clinical‑stage bispecific T‑cell engager targeting DLL3 in China. The deal expands AbbVie’s oncology...
BioAtla, GATC raise $40M SPV – Oz‑V moves toward registrational OPSCC trial
BioAtla and GATC Health announced a $40 million special purpose vehicle to fund advancement of ozuriftamab vedotin (Oz‑V), a CAB‑ROR2 antibody‑drug conjugate, into a registrational Phase 3 study...
NMPA accepts INDs for three Henlius solid‑tumor candidates: China trials to start
Shanghai Henlius Biotech reported that China’s National Medical Products Administration (NMPA) accepted investigational new drug applications for three differentiated candidates targeting solid...
Engineered virus edits macrophage RNA in vivo: new sepsis strategy
Researchers reported a bioengineered viral system capable of performing targeted RNA editing in macrophages in vivo, demonstrating therapeutic activity in preclinical sepsis models. Published in...
NIH launches OligoTox challenge: $500K prizes to map oligonucleotide toxicity
The National Center for Advancing Translational Sciences (NCATS) announced the OligoTox Open Data Challenge, a two‑phase NIH prize competition offering up to $500,000 to generate high‑quality open...
Shenzhen Edge prices HKEX IPO for $154M – surgical‑robotics maker eyes global footprint
Shenzhen Edge Medical priced an initial public offering on the Hong Kong Exchange to raise HKD1.19 billion (about US$154 million) to fund R&D, scale manufacturing and expand internationally. The...
FDA clears Medtronic, CMR robotic systems – hospitals gain new surgical options
The U.S. FDA issued clearances for Medtronic’s Hugo robotic‑assisted surgery (RAS) system and CMR Surgical’s Versius Plus system, adding two competitors to the U.S. soft‑tissue surgical robotics...
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...