Opposed by womens health advocacy group National Center for Health Research, medical device industrys AdvaMed supports a CDRH and CBER proposal on a V...
FDA issues a safety alert about unapproved products claiming to prevent, treat or cure influenza.
Biogen and AbbVie announce the worldwide withdrawal of Zinbryta (daclizumab)for relapsing multiple sclerosis due to safety concerns.
President Donald Trump says the federal government will bring lawsuits against pharmaceutical companies that may have used false, deceptive or unfair ...
FDA clears an Alfa Scientific Designs 510(k) for its Simple Cup multi-drug test with Driven Flow, a multi-drug of abuse urine test.
Federal Register notice: FDA makes available a draft guidance on Standardization of Data and Documentation Practices for Product Tracing.
Federal Register notice: FDA makes available a guidance entitled E18 Genomic Sampling and Management of Genomic Data.
FDA accepts for review a Jazz Pharmaceuticals NDA for solriamfetol, an investigational medicine for treating excessive sleepiness in adult patients wi...