FDA releases a draft guidance on Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notification (510(k)) Submi...
FDA issues SCA Pharmaceuticals a six-observation Form 483 after a November inspection cited GMP issues at the drug outsourcing facility.
A year after Bayer stopped selling and distributing its Essure implantable contraceptive device, CDRH director Jeff Shuren says Bayer has repossessed ...
FDA says Appco and Northwind have recalled ranitidine and Mylan has recalled nizatidine due to potential NDMA contamination.
Regeneron reports positive results from the LUMINA-1 trial of its garetosmab in treating fibrodysplasia ossificans progressiva.
Health IT News reports that Google is making the FDA MyStudies open-source platform available on Google Cloud.
FDA approves a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating certain adults with unresectable or metastatic gastrointestinal stromal ...
Federal Register notice: FDA proposes to withdraw approval of 249 ANDAs from multiple companies because they have repeatedly failed to file required a...