sNDAEMA2017-07-11 08:27Read 6
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis.
sNDAAmgen2017-07-11 08:27Read 7
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vectibix® (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
sNDANovartis2017-06-28 08:41Read 7
Sandoz announced today that the European Commission (EC) has approved Erelzi® (biosimilar etanercept) for use in Europe
CombinationEMA2017-06-27 08:41Read 11
The European Medicines Agency (EMA) has approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR /HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.