The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...

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 ...

Novartis has lost a bid to keep a generic version of its top-selling heart failure drug Entresto off the U.S. market by ...

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 ...

New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking approval for an experimental medication for the neurological condition.

Innovative application of an existing drug offers promising alternative treatment to traditional chemotherapy for patients with appendix cancer.

Bayer notches up pressure on rival Astellas’ Veozah with an EU marketing authorisation application for its hot flash relief ...

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specia ...

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 ...