FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Novo Nordisk PADE Reporting Violations

[ Price : $8.95]

FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.

CGMP Violations at Fareva Morton Grove

[ Price : $8.95]

FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility...

FDA Issues Early Alert on Erbe Flexible Cryoprobes

[ Price : $8.95]

FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that som...

Hims & Hers Super Bowl Ad Hit

[ Price : $8.95]

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement act...

FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

[ Price : $8.95]

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are li...

FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site

[ Price : $8.95]

FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of s...

Vertex Reports Positive Interim Phase 3 Data for Povetacicept

[ Price : $8.95]

Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept signific...

Capricors Duchenne Cell Therapy BLA Resubmitted

[ Price : $8.95]

FDA accepts for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat he...

FDA OKs Leucovorin for Ultra-Rare Brain Disorder, But Not Autism

[ Price : $8.95]

FDA approves an expanded use of GSKs Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and...

Xenon Reports Positive Phase 3 Data for Epilepsy Drug

[ Price : $8.95]

Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in p...