Regulatory
Verona Pharma’s COPD candidate hits the mark in late-stage testing.
The FDA placed a clinical hold on Entrada’s experimental DMD candidate.
The FDA lifted its partial clinical hold on bluebird’s experimental sickle cell disease gene therapy for patients younger than 18.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee stood against Cytokinetics, Inc., finding that the benefits of its heart failure hopeful didn’t outweigh its risks.
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101.
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
Spectrum Pharmaceuticals made the call Friday to slash three-fourths of its workforce on the heels of a Complete Response Letter from the FDA.
The FDA has accepted Sarepta’s BLA for the accelerated approval of SRP-9001, an investigational gene therapy for DMD. Roche is responsible for commercialization outside the U.S.
BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.
PRESS RELEASES