FDA grants fast-track designation for Adicet Bios ADT-001 to treat systemic sclerosis.
FDA releases the 19-page form FDA-483 with 15 observations from an inspection at the Exela Pharma Sciences outsourcing facility in Lenoir, NC.
FDA clears a Visby Medical 510(k) for its point-of-care test for detecting respiratory infections caused by influenza A & B, and Covid-19.
FDA releases the form FDA-483 with seven observations from an inspection at Chinas Zhejiang Huahai API manufacturing facility.
FDA releases the form FDA-483 with six observations from an inspection at Indias Piramal Pharma API manufacturing facility.
FDA releases the form FDA-483 with seven observations from an inspection at Indias Indoco Remedies manufacturing facility for sterile and non-sterile ...
Data from an AstraZeneca interim analysis of its SERENA-6 Phase 3 breast cancer trial show that camizestrant in combination with a cyclin-dependent ki...
FDA clears a Google 510(k) for its Loss of Pulse Detection feature and its use on the Pixel Watch 3.
