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FDA Grants Fast Track for Alzheimers Drug

[ Price : $8.95]

FDA grants Bristol Myers Squibb fast-track status for its investigational Alzheimers therapy BMS-986446.

FDA Touts Sentinel Successes

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FDA issues a report highlighting Sentinel System activities and achievements between 2022 and 2024.

FDA, Vanda Agree on Dispute Actions

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FDA and Vanda agree to a series of actions to resolve their disputes over the companys Hetlioz and tradipitant.

CDRH Learn Module on Quality Management System

[ Price : $8.95]

A CDRH Learn module reviews the Quality Management System Regulation requirements for medical device manufacturers and the benefit...

17 New, 64 Revised Product-Specific Guidances

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FDA issues 17 new and 64 revised product-specific guidances to aid in developing generic drugs.

Umoja Bio Wins Fast Track for B-Cell Malignancies Drug

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FDA grants Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory l...

FDA Complete Response on Menkes Disease Drug

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FDA issues a complete response letter to Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, regarding their...

FDA Approves Novartis Rhapsido for Urticaria

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FDA approves a Novartis NDA for Rhapsido (remibrutinib), a Brutons tyrosine kinase inhibitor for treating adults with chronic spon...

CDRH Proposing 11 Guidances for FY 2026

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CDRH releases a list of 11 final and draft guidances it plans to issue in FY 2026 if resources permit.

Makary Outlines Mission Critical Ops Under Shutdown

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FDA commissioner Marty Makary tells employees affected by the government shutdown that the agency will continue mission-critical a...