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BeiGene says that due to inspection scheduling issues, FDA has deferred approval for Tevimbra (tislelizumab) in first-line unresec...[ Price : $8.95]
A supplemental NDA for Novo Nordisks weight-loss drug Wegovy (semaglutide) that is seeking a heart failure indication is withdrawn...[ Price : $8.95]
FDA tells the DC District Court that a recent Novartis lawsuit that seeks a preliminary injunction to reverse the agencys approval...[ Price : $8.95]
FDA approves Medtronics Simplera disposable continuous glucose monitor.[ Price : $8.95]
FDA accepts for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating certain adults with panc...[ Price : $8.95]
CDRH publishes a discussion paper to seek public feedback on the issue of health equity in the context of medical devices.[ Price : $8.95]
Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) introduce a bipartisan bill entitled Innovation in Pediatric Drugs Act (...[ Price : $8.95]
Smiths Medical corrects software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may o...