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FDA Publishes Data Standards Program Update

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FDA publishes the FY 2025 Quarter 2 update to the CBER/CDER Data Standards Program Action Plan.

Clarametyx Gets Fast Track for Pulmonary Infection Drug

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FDA grants Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic c...

Mectronic Medicale Multiple Violations

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FDA warns Italys Mectronic Medicale about Quality System, Medical Device Reporting, and other violations in its illegal manufactur...

Two-Day Workshop on Oncology Patient Registries

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FDAs Oncology Center of Excellence announces a two-day virtual public workshop to advance the development of patient registries in...

Philips Respironics Recalls Ventilators

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Philips Respironics recalls (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to ...

Anixa Bio Moving Breast Cancer Vaccine Into Phase 2

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Anixa Biosciences assumes full sponsorship of a Cleveland Clinic IND for ian experimental breast cancer vaccine as it heads towar...

Turmoil Led to Pazdur Overriding BLA Decision: Report

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A new report from STAT describes drug review turmoil at FDA that led to FDA Oncology Center of Excellence director Richard Pazdur ...

HHS Sean Keveney Named FDA Chief Counsel

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HHS acting general counsel Sean Keveney is appointed FDAs new chief counsel.

Dyne Gets Breakthrough Status for Duchenne Therapy

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FDA grants Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystroph...

TransMedics Gets Heart Trial Conditional Approval

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FDA grants TransMedics Group conditional approval to begin its next-generation Organ Care System ENHANCE heart trial.