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FDA Accepts TG Theraputics NDA for Lymphoma

[ Price : $8.95]

FDA accepts a TG Therapeutics NDA for umbralisib, a once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon for treating ce...

Workshop on New Drugs Regulatory Program Modernization

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Federal Register notice: FDA announces a10/30 public workshop entitled New Drugs Regulatory Program Modernization: Implementation ...

Acute Myeloid Leukemia Drug Development Guide

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FDA makes available a draft guidance entitled Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.

Draft Guide on Acute Myeloid Leukemia Drugs

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FDA makes available a draft guidance entitled Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.

FDA OKs Viltepso for Duchenne MD Mutation

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FDA approves NS Pharmas Viltepso to treat Duchenne muscular dystrophy patients with a specific confirmed gene mutation.

Covid Immunomodulatory Clinical Considerations

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CDER researchers describe efforts to develop immunomodulatory therapies for Covid-19.

Developing Male Breast Cancer Drugs

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FDA issues a guidance to help sponsors develop drugs to treat breast cancer in males.

Info Collection on Humanitarian Use Devices

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Federal Register notice: FDA seeks comments on an information collection entitled Medical Devices; Humanitarian Use Devices (HUD) ...

Info Collection on E-Records/E-Signatures

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Federal Register notice: FDA seeks comments on an information collection extension for electronic records and signatures.

Docs Should Reassure Covid Patients About FDA: Hahn

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FDA commissioner Stephen Hahn tries to reassure healthcare professionals that the agency is sticking to science and not cutting co...