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Facing a rejection from Health Canada, Biogen has withdrawn its Canadian drug application for Aduhelm (aducanumab), marking another setback for the controversial Alzheimer’s disease treatment.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…
AstraZeneca is aiming to expand the use of its dual-antibody COVID-19 treatment Evusheld (tixagevimab–cilgavimab) to nonhospitalized patients with mild-to-moderate COVID 19 based on data from a late-stage study that showed…
With 392 ayes and 28 nays, the U.S. House of Representatives passed a package of legislation late Wednesday to reauthorize the FDA’s prescription drug, generic drug, biosimilar and medical device…