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White House Credits FDA on Drug Shortages

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The White House credits FDA actions in helping to reduce cancer drug shortages.

Abbott Recalls Proclaim Pulse Generators

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Abbott recalls its Proclaim and Infinity implantable pulse generators due to complaints from patients who are unable to exit MRI m...

Madrigal NDA for Nonalcoholic Steatohepatitis

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FDA accepts for priority review a Madrigal Pharmaceuticals NDA for resmetirom and its use in treating adult patients with nonalcoh...

Oxandrin Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Gemini Laboratories Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn ...

Good Cause Guidance Needs Flexibility: PhRMA

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Pharmaceutical Research and Manufacturers of America says FDA should take a more flexible approach to determining good cause for f...

Bipartisan Legislation on Patent Listings

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Bipartisan lawmakers introduce legislation in the Senate and House to close a patent-listing loophole that drug manufacturers use ...

Panel Backs Expanded Onpattro Use

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An FDA advisory committee votes 9 to 3 that the benefits of Alnylam Pharmaceuticals patisiran (Onpattro) outweigh its risks for tr...

FDA Questions Efficacy of Patisiran sNDA

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FDA medical reviewers question the efficacy of Alnylam Pharmaceuticals patisiran for an expanded population sought in an sNDA.

FY 2022 GDUFA Science, Research Outcomes

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FDA publishes its FY 2022 report on GDUFA science and research outcomes.

Safecor Health CGMP Violations

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FDA warns Safecor Health that its Columbus, OH-based drug manufacturing facility has significant violations of CGMP requirements f...