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FDA Restarts Complete Response Letter Postings

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FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted tem...

Subcutaneous Sarclisa with On-Body Injector Approved

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FDA approves a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the the...

FDA Inspection Cites SGS North America Contract Laboratory

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An FDA inspection of SGS North America's contract testing laboratory identifies significant concerns with the firms laboratory con...

FDA Expands Approval of Keytruda-Enfortumab Vedotin Regimen

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FDA has expanded the indication for Merck's Keytruda (pembrolizumab), including its subcutaneous formulation Keytruda Qlex (pembro...

FDA Fast Tracks Arialys ART5803

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FDA grants Fast Track designation to Arialys Therapeutics ART5803 to treat anti-NMDA receptor encephalitis.

White House Looking at 3 Possible FDA Commissioners: Reports

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Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

FDA Drug, Biologics Centers Continue Workforce Decline

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CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring impro...

AstraZeneca, Ionis' Wainua Misses Phase 3 Study Endpoint

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AstraZeneca and Ionis Pharmaceuticals say that their Phase 3 CARDIO-TTRansform trial evaluating Wainua (eplontersen) in patients w...

Increase in Drug WLs Shows Structural Problem: Analysis

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Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2024 should be seen by industry...

Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.

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A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in biomedical innovation.