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High Court Pauses Limits on Mifepristone

[ Price : $8.95]

The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill ...

Scrutiny of Gene Therapy Evidence Intensifies After Recent Setbacks

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An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpin...

Alnylam Pharmas Web Promo is Misleading: FDA

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FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for it...

Bayer DTC Materials Run Afoul of FDA

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FDA issues an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prosta...

Makary Outlines Sweeping Reforms to Speed Drug Development

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FDA commissioner Marty Makary outlines his goals to overhaul how the agency reviews new drugs, aiming to reduce early-stage regula...

Turmoil, Turnover and Industry Backlash Mark Makarys Tenure

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New Bloomberg reporting that FDA is facing mounting internal strain and external criticism just over a year into commissioner Mart...

Clene Plans ALS Drug Filing After Input on Accelerated Path

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Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis therapy.

Allergans Ireland Plant Hit With 483 After Inspection

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FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland fo...

Town Hall on BLA Submissions for Cell and Gene Therapies

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FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy...

PhRMA Urges Changes to FDAs Plausible Mechanism Guidance

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PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and ...