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FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing...[ Price : $8.95]
FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.[ Price : $8.95]
FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Inno...[ Price : $8.95]
FDA and Tonix Pharmaceuticals align on the protocol for an adaptive Phase 2 study of the companys TNX-4800 to prevent Lyme disease...[ Price : $8.95]
An FDA inspection cites multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturi...[ Price : $8.95]
FDA approves Takedas Orzeyful as the first drug to treat all symptoms of narcolepsy type 1 in adults.[ Price : $8.95]
Fresenius Kabi recalls one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a label...[ Price : $8.95]
Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs...