Stay updated with breaking news from Priority Review. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
The FDA approved a new antibiotic for the treatment of certain patients with Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis; acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia.
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with...
— NDA accepted and both fruquintinib and sintilimab granted Priority Review, following Breakthrough Therapy designation in July 2023 — — First regulatory filing for fruquintinib for use in...
In an important announcement today (April 2), HUTCHMED and Innovent jointly revealed the acceptance of their New Drug Application (NDA) in China for the combination of Fruquintinib with Sintilimab.
FDA extends the review period for Applied Therapeutics' NDA for govorestat, targeting Classic Galactosemia treatment. The new action date is set for November 28, 2024. Applied Therapeutics anticipates a decision from EMA in Q4 2024.