XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT Study enrolled 180 men with metastatic hormone-sensitive prostate…
GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has accepted for review a new drug application for Nucala (mepolizumab) as an add-on…
Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered…
ZAVZPRET is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal sprayfor the acute treatment of migraine in adults Expands Pfizer’s migraine portfolio,…
Clinical data submitted are consistent with global data and support enfortumab vedotin as a platinum-free option in patients with locally advanced or metastatic urothelial cancer…
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816), announced today the…
Mar 09, 2023 Sandoz, a global leader in generic and biosimilar medicines, today signed a Memorandum of Understanding (MOU) to build a new biologics production…
The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) investigating a potential new indication to lower blood sugar along with…
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced that the U.S. Food and Drug Administration (FDA) notified the companies that the agency does…
US FDA Advisory Committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus older adult vaccine candidate GSK plc (LSE/NYSE: GSK) announced that…
FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s…
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization…