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FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the companys ac...[ Price : $8.95]
FDAs annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathwa...[ Price : $8.95]
FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufact...[ Price : $8.95]
FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra Life...[ Price : $8.95]
FDA grants Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib) for treating myelofibrosis.[ Price : $8.95]
A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect ...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, Indi...[ Price : $8.95]
Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 20...