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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...

High Court Backs Abortion Pill Access for Now

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The U.S. Supreme Court temporarily preserves nationwide access to the abortion pill mifepristone by mail, blocking a lower court r...

FDA Acting Drugs Head to Leave Agency Soon: Report

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Reuters reports that CDER acting director Tracey Beth Hoeg is expected to leave the agency just days after the resignation of form...

Democratic Health Leaders Question FDA Study Suppression

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Democratic leaders on the House Energy and Commerce Committee accuse HHS secretary Robert F. Kennedy Jr. of suppressing scientific...