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Dupixent Supplemental BLA Filed for Urticaria

[ Price : $8.95]

FDA accepts for review a Sanofi and Regeneron supplemental BLA resubmission for Dupixent (dupilumab) for treating chronic spontane...

Alert on VasoView Vessel Harvesting Devices

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FDA sends an alert about safety concerns with the use of Getinge/Maquets VasoView HemoPro Endoscopic Vessel Harvesting Systems.

Information Collection on Drug User Fee Program

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Federal Register notice: FDA seeks comments on an information collection revision entitled Prescription Drug User Fee Program.

Respironics Recalls Garbin Ventilators

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Philips Respironics recalls (Class 1) its Garbin Evo ventilators due to the potential for aerosol deposit accumulation on the devi...

Innovative Manufacturing Technologies Comments

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Two stakeholder trade associations suggest changes to an FDA strategy document on innovative manufacturing technologies.

Trump Taps RFK Jr. as HHS Secretary

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President-elect Donald Trump picks controversial FDA critic and vaccine skeptic Robert F. Kennedy Jr. as his secretary for Health ...

Guide on Nonclinical Safety for Oligonucleotides

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Federal Register notice: FDA makes available a draft guidance on nonclinical safety assessments for oligonucleotide drug products.

Atamyo OKd for Gene Therapy Trial

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FDA approves an Atamyo Therapeutics IND for a Phase 1b/2b clinical trial involving its ATA-200 gene therapy for treating rare form...

More Than 1,000 Breakthrough Device Designations

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FDA says it has granted breakthrough device designation to 1,041 devices from 2015 through the 9/30 end of the 2024 fiscal year.

FDA Approves PTC Therapeutics Kebilidi

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FDA approves PTC Therapeutics Kibilidi as the first gene therapy to treat aromatic L-amino acid decarboxylase deficiency.