FDA欲扩大真实世界数据应用,再次呼吁早期临床试验改革。
FDA wants to use more real-world data and calls again for early-phase trials reform
生物技术与制药领域的最新动态
FDA wants to use more real-world data and calls again for early-phase trials reform
Enhertu combo wins FDA approval for first-line use in metastatic breast cancer
FDA speeds up review of J&J's multiple myeloma combo treatment following positive data
With GLP-1 microdoses, Noom targets lower-BMI group outside FDA obesity drug labels
Gilead posts second Phase 3 win for new HIV-fighting drug regimen
Aviceda's geographic atrophy drug fails mid-stage study. Can it do better in Phase 3?
Palvella unwraps Phase 2 data for rapamycin gel in rare skin disease
Areteia Therapeutics to wind down after terminating Phase 3 asthma studies
Immunome's rare tumor drug passes Phase 3 test, could challenge Merck KGaA
Sanofi returns to Dren Bio for another B cell depletion therapy at $100M upfront
AI biotech Chai Discovery raises $130M Series B at $1.3B valuation
Western genetic medicine makers turn to Chinese investigator-initiated trials
Argenx cans thyroid eye disease trials of Vyvgart Hytrulo
Sobi to buy gout biotech Arthrosi for $950M upfront
Milestone finally wins FDA approval for arrythmia nasal spray
Eli Lilly’s triple-G obesity readout; The latest Endpoints 100 results; Public biotechs cash in; and more
340B sales grew 23% last year, and court battle over pilot program intensifies
Covid vaccine deaths review sent to top of FDA, but with far less certain conclusions, sources say
A 2-speed payer transformation is underway
CHMP calls to reject Anavex's Alzheimer’s pill over impurities, side effects and weak efficacy