Ropes & Gray attorneys break down a new FDA final guidance on informed consent, highlighting changes from a previous draft.
FDA approves a Gilead Veklury sNDA eliminating the need for dose adjustments when treating Covid-19 in patients with mild, moderate, or severe hepatic...
Akebia Therapeutics says it plans to resubmit an NDA to FDA for vadadustat to treat anemia due to chronic kidney disease.
FDA grants Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment combination product for treating infrarenal ...
FDA clears a Paragonix Technologies 510(k) for its next-generation donor lung preservation system, BAROguard.
Oregon State University says two research studies show that more drug approval transparency is needed.
Federal Register notice: FDA announces a 10/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss the 2024 flu virus strain...
FDA grants Taysha Gene Therapies a fast track designation for TSHA-102, an intrathecally delivered AAV9 gene transfer therapy for treating Rett syndro...
