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 announces the issuance of emergency use authorizations (EUAs) for certain medical devices related to Covid-19.
FDA publishes 32 new and revised product-specific guidances to aid in development of generic drugs and a revised list of PSGs under development.
FDA grants Karius a breakthrough device designation for its Karius Test for use in the diagnosis and management of immunocompromised patients with sus...
