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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 ...

Health Affairs Commentary Says Makary Left FDA Weaker

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Two prominent drug-policy scholars sharply criticize former FDA commissioner Marty Makary in a Health Affairs commentary, arguing ...

More FDA Turmoil: Drug, Biologics Leaders Removed

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FDA replaces the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary.

AstraZeneca Gets OK for New Hypertension Drug

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FDA approves AstraZenecas Baxfendy (baxdrostat), an aldosterone synthase inhibitor for adults with hypertension whose blood pressu...

Clinical Hold on Aardvark Trial Over Safety Issue

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FDA places a clinical hold on an Aardvark Therapeutics clinical trial on its experimental metabolic drug ARD-101 based on a cardia...