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Agency Seeks Updated Generic Accutane Labels

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FDA asks manufacturers of generic Accutane to update the drugs labeling.

FDA Backs Accelerated Pathway for UniQure Huntington's Therapy

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FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accele...

FDA, African Medicines Agency Agreement on Regulatory Harmonization

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FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the...

FDA Accepts Outlook Therapeutics' Resubmitted BLA for Lytenava

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FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for t...

CGMP Violations Found in Sante Manufacturing Records

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FDA warns Canadas Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firms manufac...

FDA Fails at Providing Risk Management Advice: Post

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North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated c...

Restrict Some Lung Cancer Drugs: Petition

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A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune chec...

Draeger Anesthesia Workstation Correction Expanded

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Draeger expands a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations u...

FDA Warns Pharmathen Over Sterility, Data Integrity Concerns

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FDA sends a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its steril...

Panel to Weigh Favorable Data on Moderna's mRNA Flu Vaccine

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A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing...