Favipiravir Just Beat Ribavirin in Lassa Fever—Now Comes the Hard Part
A Phase 2 RCT published in Nature Medicine shows favipiravir cut Lassa fever mortality with HR 0.50—but the regulatory...
SN BioScience Begins Phase 1b/2 Trial of SNB-101 for Small Cell Lung Cancer
SN BioScience begins Phase 1b/2 trial of SNB-101, a nanoparticle SN-38 formulation, in extensive-stage small cell lung cancer patients...
EyePoint’s DURAVYU Receives Third Consecutive Positive DSMC Review for Wet AMD
EyePoint's DURAVYU receives third consecutive positive safety review in wet AMD Phase 3 trials, with over 900 randomized patients...
Envudeucitinib Shows 68% PASI 90 Response in Phase 3 Psoriasis Trials
Envudeucitinib achieves 68% PASI 90 response in Phase 3 psoriasis trials, surpassing current oral therapy benchmarks at Week 24.
Cardiff Oncology Advances Onvansertib to Phase 3 for RAS-Mutated Colorectal Cancer
Cardiff Oncology advances onvansertib Phase 3 for RAS-mutated colorectal cancer after 72.2% response rate in Phase 2 trial.
Biogen’s Diranersen Shows Tau Biomarker Reduction in Phase 2 Alzheimer’s Study
Biogen's diranersen shows tau biomarker reduction in Phase 2 Alzheimer's study, signaling potential for combination therapy approaches despite missing...
Senti Biosciences Secures FDA Support for SENTI-202 Donor Selection Strategy in AML
Senti Biosciences gains FDA backing for SENTI-202 donor selection strategy in relapsed/refractory AML, with 50% complete remission rates tied...
China Filed 3,073 IND Applications in 2024. The West Hasn’t Noticed What That Number Actually Means.
China's CDE accepted 3,073 IND applications in 2024, up from 70 in 2015. For global trial sponsors, that seismic...
The Alzheimer’s Agitation Approval That Should Rewrite How We Think About Antipsychotics in Geriatric Psychiatry
Auvelity's FDA expansion into Alzheimer's agitation—peak sales now projected at $8B—exposes how long antipsychotics dominated a space where safer...
BeOne Medicines Got Caught Running a Blood Cancer Ad That Outran Its Own Data
FDA flagged BeOne's Brukinsa TV ad 'Clarity' for misleading visuals—BeOne's third OPDP enforcement letter in under 18 months. Here's...