FDA says manufacturers of non-sterile water-based drugs should take steps to guard against contamination from Burkholderia cepacia.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Piqray (alpelisib), indicated in combi...
FDA approves a Biogen labeling amendment that narrows the indication for its controversial Alzheimers therapy Aduhelm (aducanumab).
FDA alerts health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from ...
FDA accepts for priority review an AstraZeneca BLA for tezepelumab for treating asthma.
The Justice Department says Alere and a subsidiary will pay $38.75 million to resolve False Claims Act allegations involving defective INRatio blood c...
Novartis resubmits its NDA for inclisiran, resolving FDA manufacturing facility questions raised in a complete response letter.
FDA says a Quidel recall of 18,365 Lyra SARS-CoV-2 assay kits due to the potential for false-negative results is Class 1.