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Vanda gets FDA nod – First new motion‑sickness drug in 40 years
The U.S. FDA approved Vanda’s oral tradipitant (Nereus) for preventing vomiting from motion sickness, based on three pivotal studies including two real‑world phase‑3 trials. The approval ends a...
FDA issues complete response to Corcept’s relacorilant
The FDA issued a complete response letter for Corcept’s relacorilant in Cushing’s syndrome, requesting additional efficacy evidence; the company said it will meet with regulators to chart a path...
FDA greenlights motion‑sickness pill: Vanda’s market win
The U.S. Food and Drug Administration approved Vanda Pharmaceuticals’ oral drug Nereus (tradipitant), marking the first new prescription treatment for motion sickness in more than four decades....
FDA grants priority review: Axsome’s AXS‑05 for Alzheimer’s agitation
The FDA accepted and granted priority review to Axsome Therapeutics’ supplemental new drug application for AXS‑05 (Auvelity) to treat agitation associated with Alzheimer’s disease, scheduling a...
FDA issues CRL to Corcept – relacorilant setback shifts focus to oncology
The FDA issued a complete response letter (CRL) to Corcept Therapeutics for relacorilant in hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional evidence of...
Viral RNA editing in situ: new approach to treat sepsis
Researchers reported a bioengineered viral platform that performs RNA editing in macrophages in vivo to treat sepsis, as published in Nature Communications. The system combines targeted viral...
Gene therapy restores SynGAP1: seizure and behavior rescue reported
A preclinical gene‑replacement study reported restoration of SYNGAP1 function that rescued epilepsy and behavioral deficits in models of SYNGAP1‑related disorders, according to a recent...
AAV9 silence‑and‑replace prevents hereditary spastic paraplegia symptoms
Researchers published a silence‑and‑replace gene therapy using an AAV9 vector that prevented symptoms of hereditary spastic paraplegia (HSP) in preclinical models. The two‑pronged approach...
Anti‑ROR1 scFv shows preclinical activity in triple‑negative breast cancer
A team from the University of Queensland reported development of a single‑chain fragment variable (scFv) targeting the membrane‑proximal region of ROR1, demonstrating preclinical activity against...
BioAtla secures $40M SPV to advance Oz‑V into Phase 3
BioAtla and GATC Health announced a $40 million special purpose vehicle (SPV) to advance ozuriftamab vedotin (Oz‑V), a CAB‑ROR2 antibody‑drug conjugate, into a registrational Phase 3 trial for...
NCATS launches OligoTox challenge: $500k to spur oligonucleotide safety data
The National Center for Advancing Translational Sciences (NCATS) at NIH announced the OligoTox Open Data Challenge, a two‑phase competition offering up to $500,000 to generate high‑quality, open...
FDA clears Medtronic’s Hugo and CMR’s Versius Plus: rivals enter U.S. RAS market
The U.S. FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system and CMR Surgical’s Versius Plus system, expanding options in the soft‑tissue surgical robotics market long dominated by...
FDA clears first new motion‑sickness drug in 40 years: Vanda wins approval
The U.S. Food and Drug Administration approved Nereus (tradipitant) from Vanda Pharmaceuticals, marking the first new pharmaceutical for motion sickness in more than four decades. Approval was...
FDA fast‑tracks Axsome’s AXS‑05 for Alzheimer’s agitation — PDUFA set
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, assigning a PDUFA date of...
FDA issues CRL to Corcept — relacorilant pivot to ovarian cancer underway
The FDA issued a complete response letter (CRL) to Corcept Therapeutics for relacorilant in hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional efficacy evidence....
Bioengineered viruses edit macrophage RNA in vivo: new sepsis strategy
Researchers published a Nature Communications report describing a bioengineered viral platform that edits RNA inside macrophages in vivo to modulate inflammatory responses in sepsis models. The...
BioAtla and GATC close $40M SPV to push Ozuriftamab vedotin into registrational trial
BioAtla and GATC Health announced a $40 million special purpose vehicle (SPV) to advance ozuriftamab vedotin (Oz‑V, CAB‑ROR2‑ADC) into a Phase 3 registrational study for second‑line and later...
AbbVie inks China deal for DLL3‑targeted T‑cell engager — Zelgen partner
AbbVie struck a licensing and development deal in China with Zelgen Biopharmaceuticals for a clinical‑stage DLL3‑targeted T‑cell engager. The agreement grants AbbVie rights to develop and...
Henlius wins NMPA acceptance for three solid‑tumor INDs
Shanghai Henlius Biotech announced China’s NMPA accepted investigational new drug (IND) applications for three differentiated solid‑tumor candidates, advancing the company’s oncology pipeline. The...
FDA clears new rivals in soft‑tissue robotics: Medtronic and CMR get nods
The FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system and CMR Surgical’s Versius Plus system, expanding U.S. options for hospitals investing in soft‑tissue robotic platforms....