Acorda Therapeutics says a Phase 3 study of tozadenant for Parkinsons disease is linked to five deaths.
An FDA drug safety alert says that Takedas gout drug Uloric (febuxostat) may have an increased risk of heart-related death when compared to allopurino...
FDA posts a draft guidance on Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.
FDA clears an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus.
FDA approves an Ultragenyx Pharmaceutical NDA for Mepsevii (vestronidase alfa-vjbk), the first approved treatment for pediatric and adult patients wit...
FDA commissioner Scott Gottlieb announces a 2018 pilot project to evaluate efforts to make the agency hiring process more efficient and effective.
FDA releases the 2015 National Antimicrobial Resistance Monitoring System (NARMS) report showing some gains in reducing antibiotic resistance and high...
FDA warns Indias Lupin Limited about repeat CGMP violations at its drug manufacturing facilities in Goa and Indore.