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BioXcel Therapeutics plans an early 2026 supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL50...[ Price : $8.95]
FDA warns Scottsdale, AZ-based Innate Healthcare Institute that it is illegally marketing adulterated and misbranded stem cell pro...[ Price : $8.95]
FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its f...[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing ...[ Price : $8.95]
More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety a...[ Price : $8.95]
FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Ela...[ Price : $8.95]
FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subar...[ Price : $8.95]
FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of...