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China regulator keeps momentum: Hutchmed NDA accepted, Innovent ipilimumab approved
China’s NMPA accepted Hutchmed’s NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, granting priority review based on a single‑arm phase II...
ADCs accelerate: field breakout and a $40M SPV to push Oz‑V to registrational trial
After a year of expanded ADC design innovations, the antibody‑drug conjugate (ADC) field is entering a commercialization inflection with new targets, linkers and payloads reported across...
Gene therapy momentum: in vivo gains and SYNGAP1 restoration
Industry reviews label 2025 a breakthrough year for in‑vivo gene therapies, citing multiple preclinical and clinical advances that improved delivery, specificity and efficacy. In that landscape, a...
IPO wave: AI drug discovery and surgical robotics go public in Hong Kong
Two high‑profile listings targeted Hong Kong capital markets as companies pushed to fund R&D and international expansion. Insilico Medicine closed a Hong Kong IPO, delivering proceeds to...
AbbVie signs T-cell engager deal in China — Zelgen's DLL3 program expands
AbbVie struck a licensing and development deal with Zelgen Biopharmaceuticals to advance a clinical-stage DLL3-targeted T‑cell engager in China. The agreement gives AbbVie access to Zelgen’s...
Vanda gets FDA approval for motion‑sickness pill: Nereus cleared
Vanda Pharmaceuticals won FDA approval for Nereus, an oral treatment the company says is the first new medicine for motion sickness in more than four decades. The approval clears the way for a...
FDA rejects Corcept’s cortisol modulator — relacorilant denied for Cushing’s
The FDA issued a rejection for Corcept Therapeutics' selective cortisol modulator relacorilant, denying approval for the treatment of Cushing’s syndrome. Corcept disclosed the decision and will...
FDA approves Omeros’ narsoplimab — first therapy for TA‑TMA cleared
The FDA approved Omeros Corporation’s narsoplimab (Yartemlea) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), marking the first approved therapy for this...
China approves Innovent ipilimumab — Hutchmed’s FGFR NDA accepted for priority review
China’s NMPA approved Innovent Biologics’ Tabosun (ipilimumab IBI‑310) in combination with sintilimab as a neoadjuvant treatment for resectable MSI‑high or mismatch repair‑deficient colon cancer....
BioAtla, GATC form $40M SPV to advance ozuriftamab — Phase 3 planned in OPSCC
BioAtla and GATC Health announced a $40 million special purpose vehicle (SPV) transaction to fund a Phase 3 registrational trial of ozuriftamab vedotin (Oz‑V; CAB‑ROR2‑ADC) in second‑line and...
Insilico caps year with Hong Kong IPO — AI drug discovery firm raises fresh capital
Insilico Medicine completed a Hong Kong initial public offering, raising gross proceeds that mark the company’s successful public market debut after multiple attempts. The offering underscores...
Startups stumble — Nido winds down; setrusumab Phase III failures rattle Mereo, Ultragenyx
Boston‑area startup Nido Biosciences said it will wind down operations in early 2026 after Phase 2 data missed expectations, terminating its development plans. Separately, two Phase III trials of...
NIH to re‑review stalled grant applications — court settlement reopens scientific review
The U.S. National Institutes of Health agreed to evaluate hundreds of grant applications that were paused under new administration directives restricting diversity‑related research priorities. The...
Judge halts 340B rebate pilot — implementation blocked ahead of Jan. 1 rollout
A federal judge in Maine issued a temporary restraining order blocking the Health Resources and Services Administration’s 340B Rebate Model Pilot Program, which would have allowed biopharma...
Judge halts 340B rebate pilot — Court freezes rollout ahead of Jan. 1
A federal judge in Maine issued a temporary restraining order blocking the Department of Health and Human Services’ 340B Rebate Model Pilot Program from taking effect Jan. 1. The court sided with...
FDA clears Omeros’ Yartemlea — First approved therapy for TA‑TMA
The U.S. Food and Drug Administration approved Omeros Corp.’s Yartemlea (narsoplimab) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), marking the first...
China speeds oncology reviews — Innovent approved, Hutchmed NDA accepted
China’s National Medical Products Administration (NMPA) granted approval and priority review actions for two oncology programs this week, signaling continued regulatory openness to domestically...
Late‑stage setrusumab failures hammer Ultragenyx, Mereo — Stocks collapse
Two Phase III readouts of setrusumab for brittle‑bone disease missed primary endpoints, sending Ultragenyx and partner Mereo BioPharma into sharp stock declines. The programs, tested in separate...
Sanofi snaps up Dynavax programs — HBV vaccine and shingles candidate added
Sanofi expanded its vaccine portfolio by acquiring Dynavax assets, adding a hepatitis B vaccine program and a shingles candidate to its pipeline, according to a deals report. The transaction...
Insilico lists in Hong Kong — AI drug discovery IPO tops year‑end
Insilico Medicine completed a Hong Kong initial public offering, raising gross proceeds that capped the company’s multi‑year push to go public. The AI‑driven drug‑discovery firm marketed itself as...