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Sen. Johnson Probing FDA Rare Disease Denials

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Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rar...

FDA Opens New, Searchable Adverse Event Platform

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FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on ...

FDA OKs Bristol Myers Squibbs Sotyktu for Psoriatic Arthritis

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FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.

4 Major Issues Plaguing FDA: Newsweek

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A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.

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

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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

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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

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

Novo Nordisk PADE Reporting Violations

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