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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...

FDA Clears Vasorum Vascular Closure Device

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FDA clears a Vasorum 510(k) for the Celt ACD Plus vascular closure device.

Advocates Blast Hiring Quack for Autism Study

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The Autism Self-Advocacy Network sharply criticizes HHS for hiring quack David Geier to study a potential link between autism and ...

Bipartisan Patent Coordination Bill In

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A bipartisan group of five Senate Judiciary Committee members introduces legislation to establish an FDA/Patent and Trademark Offi...

FDA to Cut Another 3,500 Employees Under HHS Plan

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HHS says FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced reductions in force plan to cons...

FDA Likely to Miss Review Deadlines: Staff

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An exclusive Reuters report says FDA is likely to miss medical device user fee deadlines due to staff shortages from two rounds of...