Novartis said the European Commission has approved Tafinlar(dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer.
Janssen Research & Development, LLC said FDA has accepted for review a supplemental New Drug Application for ibrutinib (Imbruvica) for the treatment of patients with chronic graft-versus-host-disease after failure of one or more lines of systemic therapy.
Amgen announced the submission of a supplemental Biologics License Application to FDA and the European Medicines Agency for XGEVA (denosumab).
RedHill Biopharma Ltd., a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, said FDA has granted Yeliva (ABC294640) Orphan Drug designation for the treatment of cholangiocarcinoma.
ESSA Pharma Inc., a pharmaceutical company focused on the development of novel small molecule drugs for the treatment of prostate cancer, announced today the receipt of a $1.2 million payment from the Cancer Prevention Research Institute of Texas.
FDA granted regular approval to Tagrisso (osimertinib) for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy.
FDA approved Zejula (niraparib), a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
Gamida Cell announced that orphan drug designation has been granted by the European Medicines Agency's Committee for Orphan Medicinal Products regarding NiCord as a treatment for haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation.
Cota Healthcare announced the signing of a multi-year collaboration with Novartis Pharmaceuticals Corp. to help improve clinical and cost outcomes for breast cancer patients.
Novartis said FDA has accepted the company's Biologics License Application filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell therapy, in relapsed and refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia.
