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BeiGenes Tevimbra First-Line Use Deferred

[ Price : $8.95]

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

Wegovy sNDA for Heart Failure Withdrawn

[ Price : $8.95]

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supplemental NDA for Novo Nordisks weight-loss drug Wegovy (semaglutide) that is seeking a heart failure indication is withdrawn...

Court Should Deny Novartis Injunction Request: FDA

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

FDA Approves Medtronic Simplera Monitor

[ Price : $8.95]

FDA approves Medtronics Simplera disposable continuous glucose monitor.

FDA accepts Cabometyx sNDA for Pancreatic Tumors

[ Price : $8.95]

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

CDRH Health Equity Discussion Paper

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

Bill Introduced to Spur Pediatric Rare Disease Studies

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

Smiths Medical Software Correction for Infusion Pumps

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Smiths Medical corrects software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may o...

Loper Bright May End FDA Speech Ban: Attorney

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

Medtronic Recalls Nerve Monitor

[ Price : $8.95]

Medtronic recalls (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative...