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Staff Up for Breakthrough Device Recall Oversight: Post

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A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medic...

Bayer Gets Priority Review for Stroke Drug

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FDA grants Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the...

High Court Declines to Hear Medicare Drug Negotiation Challenge

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The U.S. Supreme Court declines to hear a series of pharmaceutical industry challenges to the governments Medicare drug price nego...

FDA Covid-19 Pediatric Review Raises New Scrutiny

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FDA faces renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the rele...

Bayer sNDA for Hyrnuo Granted Priority Review

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FDA grants Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with ...

Open Letter to Trump Urges FDA Push on Rare Diseases

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In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targetin...

Regeneron Melanoma Trial Misses Primary Endpoint

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Regeneron Pharmaceuticals says its Phase 3 trial evaluating the experimental immunotherapy combination of fianlimab and cemiplimab...

Mercks Sac-TMT Gets Win in Endometrial Cancer

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Merck reports that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan me...

FDA Guide Reshaping Off-Label Communications: Legal Analysis

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A legal analysis reviews how an FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can com...

DTC Crackdown Unfazed at Post-Makary FDA: Expert

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DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary is unlikely to result in major ...