Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to […]readmore
Tags : F2G
Shots: The US FDA has granted BTD to Olorofim for the treatment of CNS Valley Fever (coccidioidomycosis) The therapy is currently being evaluated in P-IIb study in patients with coccidioidomycosis […]readmore
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to […]readmore
Shots: The BT designation follows the P-IIb Trial in patients with IFD or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents The study resulted […]readmore