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Sanofi Scraps Tolebrutinib MS Filing after Phase 3 Miss

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Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet...

Restrictions on Real-World Evidence Regulatory Reviews Eased

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FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data wit...

2 Guides Posted on Product Safety Reporting

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FDA posts two final guidances that provide recommendations to help clinical investigators comply with the safety reporting require...

GAO Flags Staffing Gaps and Legal Limits With Device Recalls

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The Government Accountability Office urges HHS to shore up staffing and reassess legal authorities at FDA after finding significan...

FDA OKs Enhertu Combo as First-Line for Advanced Breast Cancer

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FDA approves Daiichi Sankyos Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentechs pertuzumab as a first-line t...

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...

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...