FDA joins with the NIH and other organizations in a new Accelerating Medicines Partnership program on heart failure.
FDA approves Amylyxs amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol).
The Senate unanimously approves legislation to end an FDA mandate for animal testing of experimental drugs before they can be used in human clinical t...
FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.
Writing in a medical journal, CDER researchers say manufacturing-related deficiencies contribute significantly to a low first-review-cycle approval ra...
FDA publishes a revised guidance on medical device data systems to conform with the 21st Century Cures Act.
Four stakeholders suggest ways FDA could improve a draft guidance on fit-for-use clinical outcome assessments.
FDA approves Bimeda Animal Healths SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Healths Adspec.
FDA publishes a guidance on preparing 510(k) submissions for display devices intended for diagnostic radiology.