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FDA Looking Into Counterfeit Ozempic: Report

[ Price : $8.95]

CBS News says a drug supply chain association issued an alert that FDA is investigating counterfeit Ozempic.

NextGen Portal Accepts OTC Monograph Files

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CDER says its NextGen Portal is now accepting Over-the-Counter Monograph Order Requests.

Coherus Refiles Udenyca Onbody BLA Supplement

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Coherus BioSciences resubmits a BLA supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilg...

AstraZeneca Comments on FDA QTc Draft Guidance

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AstraZeneca suggests several things FDA could add to a draft guidance on QTc information in drug and biologic labeling.

Reagan-Udall Strategies to Understand Regulated Products

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The Reagan-Udall Foundation publishes a report with strategies for FDA to consider to improve public understanding of FDA and its ...

FDA Unsatisfied with Philips Respironics Recall

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CDRH director Jeffrey Shuren says FDA believes there is more Philips Respironics needs to do as part of its recall of ventilators ...

Stimulant Use Disorder Treatment Guidance

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FDA publishes a draft guidance to assist sponsors in developing drugs and biologics to treat stimulant use disorders.

Orphan Status for Pancreatic Cancer Drug

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FDA grants Noxopharm an Orphan Drug Designation for CRO-67, a drug candidate for treating pancreatic cancer.

Medtronic Warns on Stolen Laryngoscopes

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Medtronic warns healthcare professionals about stolen defective McGRATH MAC video laryngoscopes that have been offered for sale il...

No Safety Issues in Biosimilar Switches: Study

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FDA researchers say they found no difference in safety when patients were switched between interchangeable biosimilars and the ref...