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Corcepts Relacorilant Shows Promise in Ovarian Cancer

[ Price : $8.95]

Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-pacli...

Medtronic Recalls Aortic Root Cannulas

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Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device...

Smallpox/Mpox Vaccine OKd Despite CBER Turmoil

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FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Pe...

FDA Green Lights At-Home Sexual Disease Test

[ Price : $8.95]

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 ...

Milestone Misses Approval on Irregular Heart Beat NDA

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FDA sends Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to con...