An FDA safety alert warns about an increased risk of a false positive result with Becton Dickinsons BD SARS-CoV-2 Reagents for the BD Max System test....
Federal Register notice: FDA seeks comments on an information collection extension for Exceptions or Alternatives To Labeling Requirements for Product...
The Justice Department says Novartis will pay $678 million to settle a whistleblower suit alleging that it operated a sham speaker program to funnel m...
The CDER Office of Prescription Drug Promotion proposes to test whether consumers are challenged by TV ads that promote more than one indication for a...
Federal Register notice: FDA makes available a guidance on Unique Device Identification Compliance Dates for certain dates.
FDA approves Genentechs outpatient breast cancer drug Phesgo.
Federal Register notice: FDA makes available a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population.
FDA approves a new indication for Mercks Keytruda to treat specified forms of colorectal cancer.