FDA Related News

Marketing

FDA Cites Krazati Provider Web Page

The CDER Office of Prescription Drug Promotion says a Mirati Therapeutics provider Web page for Krazati makes false and misleading efficacy claims for...

Human Drugs

BeiGenes Tevimbra First-Line Use Deferred

BeiGene says that due to inspection scheduling issues, FDA has deferred approval for Tevimbra (tislelizumab) in first-line unresectable, recurrent, lo...

Human Drugs

Wegovy sNDA for Heart Failure Withdrawn

A supplemental NDA for Novo Nordisks weight-loss drug Wegovy (semaglutide) that is seeking a heart failure indication is withdrawn to add additional d...

Human Drugs

Court Should Deny Novartis Injunction Request: FDA

FDA tells the DC District Court that a recent Novartis lawsuit that seeks a preliminary injunction to reverse the agencys approval of MSN Laboratories...

Medical Devices

FDA Approves Medtronic Simplera Monitor

FDA approves Medtronics Simplera disposable continuous glucose monitor.

Human Drugs

FDA accepts Cabometyx sNDA for Pancreatic Tumors

FDA accepts for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating certain adults with pancreatic and extra-pan...

Medical Devices

CDRH Health Equity Discussion Paper

CDRH publishes a discussion paper to seek public feedback on the issue of health equity in the context of medical devices.

Human Drugs

Bill Introduced to Spur Pediatric Rare Disease Studies

Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) introduce a bipartisan bill entitled Innovation in Pediatric Drugs Act (S 4905) that would a...

Medical Devices

Smiths Medical Software Correction for Infusion Pumps

Smiths Medical corrects software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may occur if the device i...

Loper Bright May End FDA Speech Ban: Attorney

Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new Loper Bright Suprem...