FDA approved the marketing of 23andMe's Bloom Syndrome carrier test, a direct-to-consumer genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the disorder.
FDA approved lenalidomide (Revlimid) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
Novartis said FDA has accepted the company's supplemental New Drug Application for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive as detected by an FDA-approved test.
Mylan N.V. and Biocon Ltd. said the FDA has accepted Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.
MIODx said it has signed an exclusive license for two key immunotherapy technologies from the University of California, San Francisco.
Amgen announced on Tuesday the submission of a supplemental Biologics License Application to the FDA for Blincyto, or blinatumomab, to include overall survival data from the phase 3 TOWER study, supporting the conversion of Blincyto's accelerated approval to full approval.
Bristol-Myers Squibb Canada Co. announced last Friday the company reached an agreement with the pan-Canadian Pharmaceutical Alliance for the immuno-oncology treatment Opdivo, or nivolumab, bringing patients with advanced, difficult-to-treat cancers closer to accessing a new treatment option.
Immunomedics Inc. entered into a global licensing agreement with Seattle Genetics Inc. to develop, fund, manufacture and commercialize IMMU-132, Immunomedics' proprietary solid tumor therapy candidate.
FDA approved the nivolumab (Opdivo) injection for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
GenomeDx Biosciences and Astellas announced a collaboration to apply genomic tumor profiling using GenomeDx's Decipher Classifier and Decipher GRID as a potential aid in identifying prostate cancer patients undergoing active surveillance who may benefit from treatment with enzalutamide (Xtandi).
