FDA clears a DePuy Synthes 510(k) for the VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.
FDA clears a Genetic Signatures 510(k) for its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow.
FDA leaves a one-item Form FDA-483 after an inspection last month at Cipla Ltd.s Maharasthra, India active pharmaceutical ingredient and finished dosa...
FDA says there were 55 new drug shortages in CY 2023 and 236 potential shortages that were prevented through efforts by the agency, manufacturers, and...
Replimune plans a BLA submission for its RP1 therapy in combination with nivolumab for treating melanoma patients whove failed an anti-PD1 therapy.
Federal Register notice: FDA issues an order debarring Marina Sievert for 10 years from importing or offering for import any drug into the U.S.
Medexus Pharmaceuticals says FDA has accepted for review its Medac licensors resubmitted NDA for treosulfan, indicated for combination use with fludar...
FDA medical reviewer raise some issues about Lillys investigational Alzheimers drug donanemab for advisory committee members to consider.
