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PTC Therapeutics Phenylketonuria Drug Approved

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FDA approves a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylke...

User Fee Rates Set for FY 2026

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FDA posts the user fee rates for fiscal year 2026 for prescription drugs and biologics, biosimilar, medical devices and generic dr...

Multiple Violations at Onkos Surgical

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FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medica...

CGMP Deviations in Macsen Drugs Inspection

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FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.

Recognify Reports Mixed Data on Schizophrenia Drug

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Recognify Life Sciences says its Phase 2b trial of inidascamine, a drug candidate for treating cognitive impairment associated wit...

Input Sought on Controversial Menopause Expert Panel

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After being criticized for attempting to bypass a formal advisory committee review of warnings associated with hormone replacement...

Guide on Aluminum Content in Parenteral Drugs

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FDA issues a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral...

FDA Probes New Death of Boy Who Got Elevidys

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FDA investigates another death of a young boy who received Sarepta Therapeutics gene therapy Elevidys for Duchenne muscular dystro...

Roche Reports Positive Data on Alzheimers Drug

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Roche announces new data on its Alzheimers therapy trontinemab and its plans to begin two Phase 3 clinical trials by the end of th...

House Reps Urge FDA Action on Counterfeit Obesity Drugs

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Bipartisan House lawmakers urge FDA to block counterfeit anti-obesity medications entering the U.S.