Novartis announced today that the U.S. Food and Drug Administration accepted the company’s supplemental New Drug Application and granted Priority Review designation to Promacta (eltrombopag) in combination with standard immunosuppressive therapy for the first-line treatment of severe aplastic anemia.
Normal immune cells that live near milk ducts in healthy breast tissue may play a key role in helping early breast cancer cells leave the breast for other parts of the body, researchers say.
GW Pharmaceuticals plc announced that the U.S. FDA accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Epidiolex (cannabidiol or CBD) as an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
Genentech announced that the U.S. FDA approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
US FDA Accepts Regulatory Submission for Tagrisso in First-Line EGFR-Mutated Non-Small Cell Lung Cancer
Breakthrough Therapy Status, Clinical Trials, CNS, EGFR tyrosine kinase inhibitors (TKI), FDA, Metastases, Mutations, New England Journal of Medicine, Non-Small Cell Lung Cancer (NSCLC), Priority Review Status, Supplemental New Drug Application (sNDA)AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.