FDA提议削减美国早期试验用户费用,对海外研发额外收费。
FDA floats user fee cuts for early-stage US trials, additional fees for overseas development
生物技术与制药领域的最新动态
FDA floats user fee cuts for early-stage US trials, additional fees for overseas development
Capricor's phase 3 win sets up 2nd approval attempt for Duchenne cell therapy
Olympus-backed robotics startup Swan EndoSurgical taps Stryker vet for CEO
Fierce Biotech Fundraising Tracker '25: Triana glues $120M series B; Protego raises $130M
FDA approves next-gen prostate cancer PSA test from Cleveland Diagnostics
With site 'irregularities,' Bristol Myers delays key Cobenfy readout in Alzheimer's psychosis
Pfizer-backed Triana scores $120M series B to take molecular glue degrader into clinic
Janux T-cell engager data sink stock, but analysts still see best-in-class potential
FDA issues draft guidance to reduce primate testing for certain antibodies
Boston Scientific claims European approval for Farapoint focal pulsed field ablation catheter
CDER head Richard Pazdur set to retire shortly after appointment
Imvax takes brain cancer cell therapy to FDA, betting survival hit will overshadow primary miss
Tiziana to spin out IL-6 drug into new company, citing Big Pharma's interest in modality
Novocure promotes new CEO, replacing current chief after less than a year
Roche's point-of-care whooping cough test greenlighted in US, Europe as cases surge
FDA adopts agentic AI in latest push to infuse artificial intelligence into agency
Regeneron makes $150M bet on Tessera's rare disease gene writing prospect
European Union teams up with Angelini to funnel €150M to European health startups
Belite brings FDA filing into view with phase 3 Stargardt disease victory
GE HealthCare, Philips, Siemens spotlight AI-forward imaging at RSNA 2025