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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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Sanofis New Hemophila Drug Approved

[ Price : $8.95]

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

[ Price : $8.95]

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

Advocates Blast Hiring Quack for Autism Study

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...