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Exelas Fentanyl Not Withdraw Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Exela Pharma Sciences fentanyl citrate injections, equivalent to 2.5mg/50mL and 5mg/1...

Mirum Pharma Wins Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA announces that it issued Mirum Pharmaceuticals a priority review voucher for its approved rare pediat...

Leqvio Successfully Lowers LDL-C: Study

[ Price : $8.95]

Novartis says its Leqvio successfully lowered LDL cholesterol as a monotherapy in the Phase 3 V-MONO trial.

FDA Warns Companies on Unapproved CPAP Cleaners

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FDA warns three companies illegally marketing CPAP cleaning/sanitizing devices in the U.S.

Soleno Therapeutics NDA for Prader-Willi Drug

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FDA accepts for priority review a Soleno Therapeutics NDA for DCCR (diazoxide choline) for treating Prader-Willi syndrome (PWS) in...

SpringWorks Therapeutics NDA Accepted by FDA

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FDA accepts for priority review a SpringWorks Therapeutics NDA for mirdametinib, an investigational MEK inhibitor for treating ped...

Liveyon Founder Pleads Guilty

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Liveyon founder and CEO John Kosolcharoen pleads guilty to a felony charge of introducing an unapproved new stem cell product into...

Malfunction Reporting Program Guidance

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FDA publishes a guidance describing and clarifying several aspects of the Voluntary Malfunction Summary Reporting program.

Require More Breakthrough Postmarket Studies: Research

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Researchers call on FDA to require postmarketing studies for breakthrough therapy-designated drugs studied with surrogate endpoint...

Abbott Class 1 Recall of FreeStyle Libre Sensors

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Abbott Diabetes Care begins a Class 1 recall (device correction) of its FreeStyle Libre 3 sensors based on users reporting situati...