FDA granted Fast Track Designation for HS-410 (vesigenurtacel-L) for the treatment of non-muscle invasive bladder cancer.
FDA approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma.
Array BioPharma Inc. announced the completion of both the binimetinib and encorafenib definitive agreements with Novartis.
Amgen launched the Neulasta (pegfilgrastim) Delivery Kit in the U.S.
Bristol-Myers Squibb Co. and Bavarian Nordic formed an agreement providing Bristol-Myers Squibb an exclusive option to license and commercialize Prostvac, Bavarian Nordic's investigational phase III prostate-specific antigen targeting immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer, in a deal worth up to $975 million.
AbbVie announced a definitive agreement to acquire Pharmacyclics and its flagship asset Imbruvica for $21 billion. Under the terms of the transaction, announced March 4, AbbVie will pay$261.25 per share, comprised of a mix of cash and AbbVie equity.
FDA launched a mobile application designed to speed public access to information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix (panitumumab) to include combination with FOLFIRI as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer.
FDA granted Breakthrough Therapy Designation to EBV-CTL for the treatment of Epstein-Barr Virus following transplant of bone marrow stem cells.
FDA granted accelerated approval to Farydak (panobinostat) for the treatment of multiple myeloma. The FDA had previously granted Farydak priority review and an orphan product designation.
