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FDA Defers Action on BeiGene BLA

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FDA defers action on a BeiGene BLA for tislelizumab to treat some squamous cell carcinoma patients.

Inspection of Denmark Monkeypox Vaccine Facility Completed

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FDA completes an inspection in Denmark of Bavarian Nordics monkeypox vaccine manufacturing plant, a step that will lead to the rel...

House Urges Senate to Pass User Fee Reauthorization

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The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.

FDA Debars Hampton-Bey Over Misbranded Drugs

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Federal Register notice: FDA issues an order debarring Kris A. Hampton-Bey II for a period of five years from importing any drug i...

Regulatory Review Period for Dr. Reddys Xeglyze

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dr. Reddys Xeglyze (abameta...

Hikmas Reglan Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to...

CA Court Should Reject New Drug Liability Theory: WLF

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Washington Legal Foundation says a California appeals court should reverse a trial court ruling holding Gilead liable for not deve...

FDA Approves 3 More Centinel Spine Disc Devices

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FDA approves three additional Centinel Spine cervical total disc replacement devices.

Bill Would Take Food From FDA Responsibilities

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Rep. DeLauro and Sen. Durbin sponsor legislation to create a separate Food Safety Administration that would be responsible for all...

American Contract Test Kits Recall is Class 1

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FDA says the American Contract Systems recall of two test kits is Class 1.