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Labeling Changes for Testosterone Products: FDA

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FDA orders testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outc...

Lawyers Say Government Shutdown Could Stall Reviews

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FDAs ability to use its user fee carryover balances to fund product review operations during a potential government shutdown is un...

Odactra Approved for Expanded Use

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FDA approves an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-...

Zevra Selling Priority Voucher for $150 Million

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Zevra Therapeutics agrees to sell its Rare Pediatric Disease Priority Review Voucher for $150 million.

ROi CPS Recalls Newborn Kits

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ROi CPS recalls its newborn kits after receiving an Urgent Field Safety Notice for a kit component from supplier Mercury Medical.

Praxis to Finish Study Despite Data Miss

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Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis recommendation that a clinical trial...

FDA Suddenly Cancels Crucial Flu Vaccine Meeting

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In a move linked to HHS secretary Robert F. Kennedy Jr., FDA suddenly cancels a 3/13-planned Vaccines and Related Biological Produ...

Fast-Track for Adicet Systemic Sclerosis Drug

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FDA grants fast-track designation for Adicet Bios ADT-001 to treat systemic sclerosis.

19-Page Exela Pharma Sciences FDA-483

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FDA releases the 19-page form FDA-483 with 15 observations from an inspection at the Exela Pharma Sciences outsourcing facility in...

FDA Clears Visby Respiratory Health Test

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FDA clears a Visby Medical 510(k) for its point-of-care test for detecting respiratory infections caused by influenza A & B, and C...