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Human Drugs

Sen. Warren Continues to Push for TrumpRx Contracts

Sen. Elizabeth Warren says she is continuing to push Trump officials to release the actual contracts that have been signed with drug companies that ar...

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Human Drugs

Psychedelic Drug Hearing Focuses on Access, Safety

Stakeholders stress issues involving access and safety at an FDA hearing on psychedelic drug regulation.

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Biologics

FDA Clears Path for Rocket to Complete Pivotal Gene Therapy Trial

FDA agrees to key elements of Rocket Pharmaceuticals modified pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the company to continue enr...

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Human Drugs

Bill to Make Pediatric Rare Disease Voucher Permanent

Six House members introduce bipartisan legislation to make the FDA Rare Pediatric Disease Priority Review Voucher Program permanent.

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FDA General

Cassidy Remains Noncommittal on Overton FDA Nomination After Meeting

Senate HELP Committee chairman Bill Cassidy (R-La.) keeps mum on any potential support for FDA commissioner nominee Heidi Overton following a meeting ...

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Human Drugs

FDA Taking Expedited IND Pilot Applications

FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8-10 applicants chose...

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Medical Devices

FDA Launches Medical Device Regulatory Reliance Portal

CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device reviews and regulatory decisions to streamline their ...

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Human Drugs

CGMP Issues at Bausch and Lomb Tampa Facility

FDA warns Bausch and Lomb about CGMP violations at its Tampa, FL, drug manufacturing facility.

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Human Drugs

Etcamah Misses Endpoint in First-Line Breast Cancer Trial

AstraZeneca says that its Etcamah (camizestrant) failed to significantly improve progression-free survival in the Phase 3 SERENA-4 trial testing the o...

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FDA General

FDA Needs Workforce Rebuilding, Less Political Interference: Sinha

Saint Louis University law professor Michael S. Sinha says FDAs next commissioner should focus on rebuilding the agencys depleted workforce, restoring...