The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...
New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking ...
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...
Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. But with ...
The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal ...
A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of ...
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specia ...
Bayer notches up pressure on rival Astellas’ Veozah with an EU marketing authorisation application for its hot flash relief ...
acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low ...
Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children ...
Lo, PhD, has been appointed the new Editor-in-Chief of the journal ASSAY and Drug Development Technologies. Dr. Lo is ...