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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....
Gene‑therapy advances: SynGAP1 restoration and SPAST‑AAV9 prevent HSP in models
Two gene‑therapy reports outlined translational progress in distinct neurological disorders. Researchers demonstrated that restoring SynGAP1 expression via gene therapy rescued epilepsy and...
New tumor immune‑evasion mechanisms challenge PD‑L1 therapies
Two studies revealed tumor‑intrinsic mechanisms that blunt immune checkpoint efficacy. Zhao et al. (Cell Research, 2026) reported that tumor PD‑L1 can trigger beta‑2 microglobulin (β2m)...
Vanda wins FDA nod: first motion-sickness drug in 40 years
The U.S. Food and Drug Administration approved Nereus (tradipitant) from Vanda Pharmaceuticals, marking the first new prescription treatment for motion sickness in more than four decades. Approval...
Axsome gets priority review: agitation in Alzheimer’s heads to April PDUFA
The FDA accepted Axsome Therapeutics’ supplemental NDA for AXS-05 to treat agitation in Alzheimer’s disease and granted priority review, assigning a PDUFA date of April 30. The agency’s acceptance...
FDA issues complete response for relacorilant — Corcept pivots to ovarian cancer
The FDA issued a complete response letter (CRL) to Corcept Therapeutics for relacorilant in patients with hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional...
FDA clears two robotic platforms: more options for hospitals
The U.S. FDA cleared Medtronic’s Hugo robotic-assisted surgery (RAS) system and CMR Surgical’s Versius Plus system, expanding the pool of cleared robotic platforms for soft-tissue procedures. The...
Shenzhen Edge files HKEX IPO: $154 million to scale surgical-robotics push
Shenzhen Edge Medical announced a HKEX initial public offering to raise HKD1.19 billion (about US$154 million) to fund R&D and international expansion of its surgical robotics pipeline. The...
BioAtla and GATC fund registrational push for Ozuriftamab vedotin
BioAtla and AI-driven partner GATC Health announced a $40 million special purpose vehicle transaction to advance ozuriftamab vedotin (Oz‑V), a CAB-ROR2 antibody‑drug conjugate, into a Phase 3...