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CGMP Violations in Tentamus India Inspection

[ Price : $8.95]

FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.

Advita Ortho Hit with 7 QS Violations

[ Price : $8.95]

FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equin...

Rosemont Pharma Gets Complete Response on Valacyclovir

[ Price : $8.95]

FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.

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

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

Capricors Duchenne Cell Therapy BLA Resubmitted

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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...

CGMP Issues at Simtra BioPharma Solutions

[ Price : $8.95]

FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.

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...