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FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.[ Price : $8.95]
FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and tre...[ Price : $8.95]
FDA issues Adamis Pharmaceuticals a complete response letter on its NDA for Adamis ZimHi (naloxone) high-dose injection for treati...[ Price : $8.95]
CDER Office of Prescription Drug Promotion sends Rockwell Medical an untitled letter after reviewing the companys Triferic Web pag...[ Price : $8.95]
FDA accepts for review an Endo International BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the butt...[ Price : $8.95]
President Trump signs a short-term continuing resolution that funds FDA and other agencies at FY 2019 funding rates through 12/20.[ Price : $8.95]
FDA approves a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults.[ Price : $8.95]
FDA posts a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee mee...