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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...

Critics Pile on Makarys Ouster with Melanoma Drug Denial

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FDAs recent rejection of an experimental melanoma treatment becomes a flashpoint in broader criticism of former FDA commissioner M...

Early Alert on Drager Anesthesia Workstations

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FDA issues an early alert warning healthcare providers about a potentially high-risk problem involving certain anesthesia workstat...

Genentechs Tecentriq OKd for Muscle-Invasive Bladder Cancer

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FDA approves Genentechs Tecentriq (atezolizumab) and a subcutaneous formulation of the drug for the adjuvant treatment of certain ...

Sun Recalls 1 Batch of Doxorubicin HCl

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FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass particles found in some vials during...

FDA May be OK Under Loper Bright: Article

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University of Missouri law professor Erika Lietzan says FDA may not suffer as much under the Supreme Courts Loper Bright decision ...

CDER Impurity Acceptance Criteria MAPP

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CDER publishes a Manual of Policies and Procedures on approaches for assessing drug substance and drug product impurity acceptance...