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PETA Letter Hits at FDA Lab Animal 'Cruelty'

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People for the Ethical Treatment of Animals urges FDA to move away from animal experiments in its labs and use more non-animal, hu...

Pfizer BLA for Hemophilia Accepted for Review

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FDA accepts for review a Pfizer BLA for its anti-tissue factor pathway inhibitor candidate marstacimab for treating hemophilia A o...

Trump Aligned Group Sues FDA on Ivermectin

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Trump-associated America First Legal files a lawsuit against FDA and HHS for illegally concealing government records related to th...

Regulatory Review Determined for Welireg

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Peloton Therapeutics Welire...

Cardinal Health Recalls Procedure Kits

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Cardinal Health recalls its Covidien and Cardinal Health brand urology and operating room-specific kits and trays that contain 0.9...

First Sickel Cell Gene Therapies Approved

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The first two cell-based gene therapies for treating sickle cell disease in patients 12 years and older gain FDA approval Vertex ...

Novartis Reports Risk Reduction Kisqali Data

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Novartis reports updated Kisqali (ribociclib) data from the Phase 3 NATALEE trial that confirms an earlier benefit seen at an inte...

Guide on Drug Supply Chain Security

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FDA issues a guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.

Getinge Recalls CardioHelp Emergency Drive

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Getinge recalls its CardioHelp Emergency Drive due to a possible blocking or impairment of its emergency crank.

FDA Withdraws Ciprofloxacin for Cystitis

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Federal Register notice: FDA withdraws approval of Bayers Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five relate...