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FDA Puts Hold on Gilead HIV Trials

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Based on safety concerns, FDA places a clinical hold on Gileads HIV treatment trials of GS-1720, an investigational integrase stra...

OPDP Finds False, Misleading Addyi Post

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The CDER Office of Prescription Drug Promotion warns Sprout Pharmaceuticals about a social media post for its Addyi that does not ...

Contaminated Zicam and Orajel Lots Recalled

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Due to contamination concerns, Church & Dwight recalls all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and ...

No IND for American Behavioral Study: FDA

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FDA warns Boca Raton, FL-based American Behavioral Research Institute that it did not have an IND for a clinical study of Relaxium...

More Comprehensive AI Regulation Needed: Report

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U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework for AI healthcare tools.

Makary/Prasad Priorities for A New FDA

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FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call ...

Promising Insmed Data in Pulmonary Arterial Hypertension

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Insmed releases positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation...

Former FDA Regulatory Counsel Lands at Alston & Bird

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Former FDA regulatory counsel Jessica Ritsick joins Alston & Birds FDA practice in Washington, DC., after an 11-year career at the...

Innoviva NDA for Gonorrhea Antibiotic Accepted by FDA

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FDA accepts for review an Innoviva Specialty Therapeutics NDA for zoliflodacin, an investigational first-in-class spiropyrimidinet...

Can Surprise Foreign Drug Inspections Boost Safety?

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A MedShadow online post says President Trumps executive order to increase unannounced foreign drug inspections could help improve ...