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Trump Order Stifles Union Representation at FDA

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President Trump signs an executive order to remove organized union representation from the majority of government agencies, includ...

Merck Touts Data in Pulmonary Arterial Hypertension

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Merck reports data from its Phase 3 ZENITH trial that showed Winrevair (sotatercept-csrk) significantly reduces the risk of major ...

FDA Clears TrainHealths Neuromuscular Stimulator

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FDA clears a TrainHealth 510(k) for its TrainFES neuromuscular stimulator and its use in treating people with sequelae of stroke a...

FDA Loses on Regulating Lab-Developed Tests

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Eastern Texas federal judge Sean Jordan rules against FDA in a case challenging the agencys final rule regulating laboratory-devel...

FDA Green Lights At-Home Sexual Disease Test

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FDA grants Visby Medical a de novo marketing clearance for its Womens Sexual Health Test, a non-prescription at-home diagnostic te...

Meeting on Opioid Postmarketing Studies Set for 5/5

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FDA reschedules for 5/4 a previously planned joint advisory committee meeting on studies that looked at the use of opioid analgesi...

Novartis Wins Expanded Pluvicto Use in Prostate Cancer

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FDA approves a Novartis supplemental NDA to expand the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include ...

FDA Probes Data Integrity Concerns at India CRO

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FDA notifies NDA and ANDA holders about data integrity and study conduct concerns involving bioequivalence studies conducted at In...

FDA Accepts Liquidias NDA Resubmission for Yutrepia

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FDA accepts for review a Liquidia NDA resubmission for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hyper...

Sanofis New Hemophila Drug Approved

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FDA approves a Sanofi NDA for Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes ...