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FDA Requiring Less Burdensome Isotretinoin REMS

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FDA tells isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy to minimize the b...

NDA Resubmission on Hypoparathyroidism Accepted

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FDA accepts an Ascendis Pharma NDA resubmission for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism...

InvaGen Pharma Recalls Vigabatrin Lot

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Ciplas InvaGen Pharmaceuticals unit recalls one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues.

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...