After being forced to resign in April, former CBER director Peter Marks accepts a job at Lilly Research Laboratories overseeing molecule discovery and...
FDA lifts a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis.
FDA accepts for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with certain blood cancers...
FDA grants IceCure Medicals de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-risk breast cancer in w...
FDA issues Dr. Reddy's Laboratories a five-item Form FDA-483 after inspecting the firms drug substance and drug product manufacturing facility last mo...
AstraZeneca and Daiichi Sankyo report new data showing that their antibody-drug conjugate Datroway (datopotamab deruxtecan) significantly improved sur...
Abivax announces new Phase 3 data showing that its lead drug candidate, obefazimod, achieved clinically meaningful improvements across all efficacy en...
FDA approves an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in child...
