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...
FDA unveils a new pilot program to prioritize the review of certain generic drug ANDAs in an effort to boost domestic pharmaceutical manufacturing and...
FDA commissioner Marty Makary talks with CNNs Sanjay Gupta and says he wants to speed up the nations drug approval process without compromising safety...
