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NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.

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...

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...