The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 22-0, yesterday to recommend FDA authorization of Moderna’s two-dose primary series of its COVID-19 vaccine for children between the…
In a briefing document issued ahead of a two-day meeting by its vaccines advisory committee that begins today, the FDA indicated its support for Emergency Use Authorization (EUA) of the…
Vertex Pharmaceuticals’ and CRISPR Therapeutics reported positive follow-up data from two late-stage clinical trials showing continued benefit from using their gene-editing treatment for people with transfusion-dependent beta thalassemia (TDT) or…
Facing a rejection from Health Canada, Biogen has withdrawn its Canadian drug application for Aduhelm (aducanumab), marking another setback for the controversial Alzheimer’s disease treatment. Source: Drug Industry Daily
The European Medicines Agency’s (EMA’s) safety committee has recommended the withdrawal of EU marketing authorization for amfepramone obesity medicines after a review showed that “their benefits do not outweigh their…
The FDA hit Eywa Pharma’s Cranbury, N.J., drug manufacturing facility with a three-observation Form 483, citing inadequate investigations of deviations and other quality lapses. Source: Drug Industry Daily
The FDA’s Center for Biologics Evaluation and Research (CBER) said it plans to resume normal operations starting calendar year 2023 following the more than two-year focus on COVID-19, which seriously…
Forty-nine states that are suing more than 20 generic drugmakers over alleged price-fixing can’t force the companies to hand over the profits of their alleged scheme as punishment, a federal…
An FDA advisory committee voted unanimously, 13 to 0, on Friday to recommend Bluebird Bio’s investigational gene therapy betibeglogene autotemcel (beti-cel) for patients with beta-thalassemia who require regular red blood…
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic combination products if the generic…