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Human Drugs

Clinical Hold on Aardvark Trial Over Safety Issue

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

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Human Drugs

High Court Backs Abortion Pill Access for Now

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

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Human Drugs

FDA Acting Drugs Head to Leave Agency Soon: Report

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

Biologics

Democratic Health Leaders Question FDA Study Suppression

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

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Human Drugs

Critics Pile on Makarys Ouster with Melanoma Drug Denial

FDAs recent rejection of an experimental melanoma treatment becomes a flashpoint in broader criticism of former FDA commissioner Marty Makary and the ...

Medical Devices

Early Alert on Drager Anesthesia Workstations

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

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Human Drugs

Genentechs Tecentriq OKd for Muscle-Invasive Bladder Cancer

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

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Human Drugs

Sun Recalls 1 Batch of Doxorubicin HCl

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

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FDA General

FDA May be OK Under Loper Bright: Article

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

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Human Drugs

CDER Impurity Acceptance Criteria MAPP

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