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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...

FDA in Turmoil as Critics Across Washington Pile On

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FDA commissioner Marty Makarys resignation capped one of the shortest and most turbulent FDA tenures in recent memory, with media ...

Positive Data with Imfinzi Regimen in Bladder Cancer

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AstraZeneca reports positive data in a trial evaluating perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvan...

Petition Urges Actions Against Weight Loss Device

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A citizen petition urges FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say...

Add Warning to OTC Acetaminophen Product Labels: Petition

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Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instructions to labeling for over-the...