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Coordinate on Drug Patent Oversight: Senators

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Sens. Cassidy and Hassan call on FDA and the Patent and Trademark Office to better coordinate and communicate on drug patent appli...

FDA Pulls TG Therapeutics Ukoniq for Safety

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FDA says it has pulled its approval of TG Therapeutics Ukoniq for two lymphoma indications due to safety concerns.

Antimicrobial Susceptibility Test Criteria Site

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FDA launches a Web page, required by the 21st Century Cures Act, on antibacterial and antifungal susceptibility test interpretive ...

Breakthrough Therapy Designation for Efanesoctocog Alfa

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FDA grants breakthrough therapy designation to Sanofis efanesoctocog alfa to treat hemophilia A.

Value of FDA Accelerated Approval Not Proven: Researchers

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Researchers say CMS too often pays for drugs that received FDA accelerated approval but did not confirm a clinical benefit.

FDA Removes Hold on Legend CAR-T Therapy

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FDA removes a clinical hold against a Legend Biotech Phase 1 clinical trial of LB1901, an investigational autologous chimeric anti...

Stryker Q Guidance for Computer-assisted Surgery Cleared

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FDA clears a Stryker 510(k) for its Q Guidance System for advanced planning and intraoperative guidance during open or percutaneou...

FDA Denies Most Parts of 4 Dental Amalgam Petitions

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FDA denies most elements in four Consumers for Dental Choice petitions seeking additional agency actions to stop or reduce amalgam...

Esophageal Cancer Indication for BMS Opdivo

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FDA approves two indications involving Bristol-Myers Squibbs Opdivo in combination with other drugs for some esophageal cancers.

Clinical Hold on Sanofi OTC Cialis Trial

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FDA places a clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it l...