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FDA Urges Broader, More Inclusive Clinical Trials

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FDA posts updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practice...

Vanda Antibody BLA for Pustular Psoriasis

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Vanda Pharmaceuticals files a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially f...

FDA Awards Priority Voucher for Multiple Myeloma Combo

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FDA proactively awards Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating ...

Study Warns Drug Trials are Lacking Diversity

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A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clin...

FDA, Industry Debate America First User Fee Incentive

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FDA and drug-industry negotiators exchange early feedback on the agencys proposed America First fee incentives for domestic drug d...

FDA OKs Akeega for BRCA2-Mutated Metastatic Prostate Cancer

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FDA approves Janssens Akeega a fixed-dose combination of niraparib and abiraterone acetate with prednisone for adults with metas...

FDA Weighs Black Box Warning on Covid Vaccines

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FDA considers adding a Boxed Warning to Covid-19 vaccines, the latest action as part of an ongoing campaign to scrutinize and rest...

Amgens Uplizna OKd for Generalized Myasthenia Gravis

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FDA approves Amgens Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis who test positive for anti-acetylcho...

FDA Gives Expedited Review for Lilly Obesity Pill

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Senior FDA officials urge agency reviewers to speed up the review of Eli Lillys NDA for its oral weight loss pill orforglipron aft...

Exceptional Performance of TAP Pilot: Report

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An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well...