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I-Mab Gets Breakthrough for Nephropathy

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FDA grants I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membran...

FDA Continues Device Supplement Guidance

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FDA says it will continue to exercise enforcement discretion for some supplements to PMAs and HDEs.

FDA OKs Keytruda in Biliary Tract Cancer

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FDA approves Mercks Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastati...

Why Are FDA-483 Observations the Same?

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Former FDAer Steve Lynn asks what the drug industry and regulators can do working together to break the cycle of more than 20 year...

FDA Seeks Nonvoting Device Panel Members

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Federal Register notice: FDA selects interested industry organizations to participate in selecting nonvoting industry representati...

FDA Terminating Winnes Debarment

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Federal Register notice: FDA grants a special termination of the debarment of David Winne due to his cooperation with federal offi...

Panel Backs Sickle Cell Gene Therapy Safety

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FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assess...

FDA Expects Increasing Cannabis Research

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An FDA post reviews 50 years of agency involvement in cannabis research and predicts the increase seen in recent years will contin...

Unlicensed Wholesaler Sentenced to Prison

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A Florida federal judge sentences Marina Sievert to two years in federal prison for mail fraud and introducing into interstate com...

Tonix Shuts Down Depression Drug Development

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Tonix Pharmaceuticals discontinues the development program for major depressive disorder candidate TNX-601 ER based on disappointi...