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Boehringer NDA for Lung Cancer

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FDA accepts for priority review a Boehringer Ingelheim NDA for zongertinib (BI 1810631) for treating certain adult patients with u...

Mirums Ctexli Approved for Rare Lipid Disease

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FDA approves a Mirum Pharmaceuticals NDA for Ctexli (chenodiol) for treating adults with cerebrotendinous xanthomatosis.

PhRMA Suggests Revisions to Cell Therapy Guide

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Pharmaceutical Research and Manufacturers of America says FDA should revise its recommendations for sponsors requesting meetings c...

FDA Staff Exodus Deepens as CBER Deputy Witten Quits

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In another blow to FDAs institutional knowledge, CBER deputy director Celia M. Witten leaves the agency amid a deepening staff exo...

Increased Foreign Company Enforcement Likely: Attorneys

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Three Arnall Golden Gregory attorneys describe steps foreign drug and medical device companies can take to prepare for what they s...

Robert Foster Named FDA Chief Counsel

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HHS appoints Robert Fox Foster as FDAs next chief counsel.

Did Trump Ban Woman and Disabled at FDA?

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FDA staff tell Reuters a potentially bogus list of words that cant be used in external communications under a Trump Executive Orde...

LDT Court Ruling As Soon As Possible, Judge Says

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The Texas federal judge hearing the consolidated cases against FDA over its final rule on laboratory-developed tests promises a ru...

Bill for Canadian Drug Imports Reintroduced

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Sens. Charles Grassley and Amy Klobuchar reintroduce legislation to provide for safe importation of drugs from Canada.

FDA Clears Ezra Flash AI

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FDA clears an Ezra 510(k) for its Ezra Flash AI model for MRI imaging.