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Beam Gets OK to Begin Clinical Testing of PKU Gene-Editing Therapy

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FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing...

FDA Approves 1st Generic Version of Flu Drug Xofluza

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FDA approves the first generic version of Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the ...

Committee Backs Moderna Flu Vaccine

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The FDA Vaccines and Related Biological Products Advisory Committee votes to support Moderns mRNA flu vaccine mFlusiva.

FDA Wants Testosterone Therapy Labels Updated

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HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical ...

Review Memo Dismisses Hoegs Block on Tzield Approval

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FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi su...

Grace Therapeutics Preparing NDA Resubmission

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Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.

FDA Updates Device READI-Home Innovation Challenge Initiative

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FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate developme...

Expand Some Islet Cell Transplantation Access: Senators

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Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type...

Data from First 100 QMSR Inspections Analyzed

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Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new ...

Guide on Immunogenicity Data Submissions for Pharmacokinetic Reviews

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FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immu...