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FDA Mifepristone Restrictions are Legal: Judge

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A Washington federal judge says FDA acted lawfully in imposing restrictions on the availability of chemical abortion drugs mifepri...

AirLife/Vyaire Recall Infant Heated Wire Circuits

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AirLife and Vyaire recall certain infant heated wire circuits due to the risk that accessory adapters may unintentionally disconne...

Trethera Gets Fast Track for Prostate Cancer Drug

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FDA grants Trethera a fast track designation for TRE-515 for treating prostate cancer.

Biotech Leaders Support Access to Mifepristone

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A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to r...

FDA Drops REMS Need for ERA Meds

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FDA drops REMS requirements covering embryofetal toxicity risk in endothelin receptor antagonists.

CGMP Violations at Exela Pharma Sciences

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FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufacturing outsourcing facility.

Support for Biosimilar Legislation

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Forty health advocacy groups led by the Association for Accessible Medicines voice their support for legislation to eliminate the ...

FDA Prodded to Improve Surrogate Endpoint Transparency

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A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to incr...

Taiho Reports Unfavorable DMD Drug Data

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Taiho Pharmaceutical reports disappointing data from its Phase 3 extension study of TAS-205 (pizuglanstat) in patients with Duchen...

FDA Urged to Expand Real-World Data Use

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A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety a...