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Petition Seeks More Ozempic, Mounjaro Trials

[ Price : $8.95]

A petition submitted by a Charles Ludlam calls on FDA to require additional clinical trials to examine the loss of lean muscle mas...

Breakthrough Status for Anxiety Disorder Drug

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FDA grants MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disord...

PhRMA Seeks Waivers on Patient Medication Info

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Pharmaceutical Research and Manufacturers of America says FDA should allow drug companies to seek waivers from the one-page patien...

Ensartinib NDA Accepted for Lung Cancer

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FDA accepts for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult pa...

Drug Supply Small Dispenser Info Collection

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Federal Register notice: FDA seeks comments on a new proposed information collection entitled Proposed Small Dispensers Assessment...

Par Pharmaceutical Recalls 1 Treprostinil Lot

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Par Pharmaceutical recalls one lot of treprostinil injection due to the potential for the presence of silicone particulates in the...

Drug Supply Small Dispenser Info Collection

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Federal Register notice: FDA seeks comments on a new proposed information collection entitled Proposed Small Dispensers Assessment...

Nonprescription Drug Labeling Changes Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled Annual Reportable Labeling Changes for NDAs and ANDAs for N...

Draft Guide on Device Cybersecurity

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Premarket Cybersecurity Guidance: Se...

Pharmaceutical Science Advisory Panel Renewed

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Federal Register notice: FDA renews its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two ...