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Ropes & Gray attorneys break down a new FDA final guidance on informed consent, highlighting changes from a previous draft.[ Price : $8.95]
FDA approves a Gilead Veklury sNDA eliminating the need for dose adjustments when treating Covid-19 in patients with mild, moderat...[ Price : $8.95]
Akebia Therapeutics says it plans to resubmit an NDA to FDA for vadadustat to treat anemia due to chronic kidney disease.[ Price : $8.95]
FDA grants Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment combination product for ...[ Price : $8.95]
FDA clears a Paragonix Technologies 510(k) for its next-generation donor lung preservation system, BAROguard.[ Price : $8.95]
Oregon State University says two research studies show that more drug approval transparency is needed.[ Price : $8.95]
Federal Register notice: FDA announces a 10/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss the 2...[ Price : $8.95]
FDA grants Taysha Gene Therapies a fast track designation for TSHA-102, an intrathecally delivered AAV9 gene transfer therapy for ...