News

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

Under the terms of the agreement, DL Medicine will screen and collaborate with Pfizer in producing new chemical entities against pre-selected targets from multiple therapeutic areas. As part

The trial, dubbed IMmotion151, met its co-primary endpoint of progression-free survival (PFS) in patients whose metastatic renal cell carcinoma (mRCC) expressed the PD-L1 protein. In the study, the

During the mid-20th century, multiple chemical compounds with antibacterial properties were analyzed, of which few have been used for development into drugs. By using advanced science and technology, scientists

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

Feraccru is a stable, non-salt and formulation of ferric iron, which includes differentiated mechanism of action compared to salt-based oral iron therapies. The phase III trial with a primary

This acceptance follows submission of the MAA in December 2017. GW CEO Justin Gover said: “The successful filing of the MAA for Epidiolex with the EMA builds on

PFS is one of the two co-primary endpoints of the trial, dubbed CheckMate -227. Overall survival (OS) is the other endpoint. The phase 3 trial had assessed the