Across two clinical trials 82% overall response and 35% complete response ratewere observed in Chinese patients using Calquence AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine…
Nubeqa™ now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer / Additional indication based on data from the pivotal Phase…
Today, the U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as…
European Commission granted approval of Nubeqa™ (darolutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) / Approval is based on Phase III…
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the…
Darolutamide approved for metastatic prostate cancer as well as non-metastatic castration-resistant prostate cancer / New approval based on data from the pivotal Phase III ARASENS…
Approvals based on significant survival benefitsin HIMALAYA and POSEIDON Phase III trials AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for…
Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved its supplemental New Drug Application (sNDA) for CIBINQO® (abrocitinib),…
GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch…
First and only heart failure therapy with proven mortality benefitacross the full ejection fraction range Forxiga (dapagliflozin) has been approved in the European Union to extend…
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License…
Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of clinical trials,…