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Limited Covid Vaccines OKd for Upcoming Season

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FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of...

Amylyx Nixes AMX0035 Development After Failed Study

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Amylyx Pharmaceuticals discontinues development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in...

FDA Alert on Abiomed Impella Controllers

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FDA issues an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella contr...

BioXcel Plans sNDA for At-Home Bipolar Drug

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BioXcel Therapeutics plans an early 2026 supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL50...

Innate Healthcare Illegally Marketing Stem Cells: FDA

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FDA warns Scottsdale, AZ-based Innate Healthcare Institute that it is illegally marketing adulterated and misbranded stem cell pro...

Violations in Uscom Spirometer Inspection

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FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its f...

Hikma Injectables FDA-483 Out

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FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing ...

Researchers Affirm Mifepristone Safety to FDA

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More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety a...

FDA Looking at MASH Surrogate

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FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Ela...

Grace Therapeutics NDA for Hemorrhage Drug Submitted

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FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subar...