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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...

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...

2 Observations on Astellas Pharma FDA-483

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FDA releases the form FDA-483 with two observations from an inspection at the Astellas Pharma sterile drug manufacturing facility ...

Lillys Triple-Agonist Cuts Weight by Nearly 29%

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Eli Lillys investigational triple-agonist retatrutide shows substantial weight loss and meaningful reductions in knee osteoarthrit...

Healthcare Opposition to Cybersecurity Reg Change

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Cardiovascular Business reports that the American College of Cardiology has joined numerous other healthcare organizations in aski...

OpdivoAVD Priority Review for Hodgkin Lymphoma

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FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD...