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.
CDERs 10th yearly drug safety report highlights the FY 2024 establishment of two new units contributing to drug safety.
Canadian researchers find that 16% of patients in Phase 2 oncology trials receive treatments that are later approved by FDA for their condition.
