FDA’s commissioner told staff in an email that he intends to delay any labor reductions until the end of September unless Congress authorizes its user fee program to provide the necessary funding.
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 Gilead Sciences’ Vosevi, an oral medicine for the re-treatment of chronic HCV.
The FDA approved Puma Biotechnology’s breast cancer drug Nerlynx (neratinib).
FDA approved Janssen Biotech’s Tremfya (guselkumab) for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The Korea Ministry of Food and Drug Safety granted marketing approval for Invossa-K Inj., the world’s first cell and gene therapy for degenerative arthritis.
FDA approved Endari oral powder for patients 5 years and older with sickle cell disease to reduce severe complications associated with the blood disorder.
Novartis said the Committee for Medicinal Products for Human Use approved a label update for Cosentyx (secukinumab), the first interleukin-17A approved to treat psoriasis.
FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab
The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).
The European Commission approved Besponsa as monotherapy for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
Amgen announced that the U.S. FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer.