The U.S. FDA approved 60 Degrees Pharmaceuticals’ Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
The FDA approved Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include use in children ages 2-5 years with cystic fibrosis who have two copies of the F508del-CFTR mutation.
The U.S. Food and Drug Administration approved the first non-radioactive, dual-tracer for sentinel lymph node biopsy.
The FDA approved Azedra injection for intravenous use for treating patients age 12 and older with rare tumors of the adrenal gland that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.
Pfizer Inc. announced that the U.S. FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen, for all eligible indications of the reference product.
The U.S. FDA approved Symtuza, the first complete darunavir-based single-tablet regimen for the treatment of human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults.
The U.S. FDA approved TPOXX (tecovirimat), the first drug with an indication for the treatment of smallpox.
Astellas Pharma Inc. and Pfizer Inc. announced the U.S. FDA approved a supplemental New Drug Application for Xtandi (enzalutamide), following FDA Priority Review designation.
