ViiV Healthcare sues Gilead over HIV drug patent infringement
Bictegravir is one of the three drugs used in Biktarvy, which secured approval from the US Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus type
Shanghai Henlius Biotech (Henlius) and Organon have announced the US Food and Drug Administration (FDA) acceptance of the biologic license application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).
The companies have signed a global co-development and commercialization agreement that could generate up to $1bn for Theravance. Theravance's TD-1473 is an internally-discovered Janus kinase (JAK) inhibitor that has demonstrated
The approval for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF) supported by data from four ongoing phase 3 trials. Biktarvy combines bictegravir, an integrase strand transfer inhibitor, with
FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence
CAP-1002, its lead investigational cell therapy for the treatment of Duchenne muscular dystrophy, the Regenerative Medicine Advanced Therapy (RMAT) designation. In notifying Capricor, the FDA Office of Tissues