FDA updates a Draeger Class 1 recall (device correction) of the Perseus A500 anesthesia workstation after receiving reports that the internal backup b...
Biogen and Ionis Pharmaceuticals discontinue the development of BIIB105 (ION541), an investigational antisense oligonucleotide for amyotrophic lateral...
CDER review chemist Andrei Ponta discusses the recent guidance on nanomaterials in drugs and biologics on a Center small business assistance podcast.
The Sedgwick Recall Index for the first quarter of 2024 shows a drop in drug recalls and an increase in medical device recalls.
In an ongoing review of problems with plastic syringes made by some manufacturers in China, FDA says it has imposed an Import Alert on two companies t...
FDA gives Amgen accelerated approval for its BLA for Imdelltra (tarlatamab-dlle) for extensive stage small cell lung cancer in patients experiencing d...
Federal Register notice: FDA issues an order permanently debarring Gina Acosta from providing services in any capacity to a person that has an approve...
Federal Register notice: FDA posts a technical amendment to its animal drug regulations for labeling new animal drugs included on the agencys Index of...
