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Advocacy Push Precedes FDA Meeting on Stalled Gene Therapy

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AMT-130 is a gene therapy designed to lower levels of the mutant huntingtin protein believed to drive Huntingtons disease progress...

Symposium on Clinical Trials, Bioequivalence and Pharmacovigilance

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U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for c...

FDA Reports Gains in Drug Inspection Program

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FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong perf...

Testing Deficiencies Cited at Asahi Kasei Finechem API Plant

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FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the companys ac...

FDA Highlights Expedited Pathways in Drug Approval Report

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FDAs annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathwa...

Advocacy Groups Press Congress on Biosimilar Legislation

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Advocacy groups urge Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-cal...

Sanofi Reports Positive Data for Atopic Dermatitis Drug

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Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-s...

FDA OKs Guardant360 CDx Companion Diagnostic

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FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant m...

FDA Drug Ad Enforcement Letters Hit 25-Year High

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Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 20...

Corcept Reports Promising Survival Data for Ovarian Cancer Drug

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As its NDA is currently under FDA review, Corcept Therapeutics says its experimental drug relacorilant met the overall survival pr...