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...
The Humane Society of the U.S. petitions FDA to take actions to inform drug developers and sponsors that they are not always required to perform anima...
The Alliance for a Stronger FDA urges Congress to provide FDA with $3.9 billion in budget authority for fiscal year 2025, which is more than $200 mill...
