U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer Approval Supported by Data from Phase 3 Head-to-Head Study vs. Gefitinib NEW YORK, N.Y., September 27 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration...
Merck KGaA, Darmstadt, Germany to Develop Abituzumab in Metastatic Colorectal Cancer with SFJ Pharmaceuticals Group Agreement enables Merck KGaA, Darmstadt, Germany, to further develop abituzumab through a novel risk-sharing collaboration agreement SFJ Pharmaceuticals Group to develop abituzumab as a first-line treatment for metastatic colorectal cancer...
WEDNESDAY, NOVEMBER 1, 2017 The U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (GO) for two patient populations: adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) and children ≥2 years old with relapsed or refractory CD33-positive AML. GO originally received accelerated approval in May 2000...
PFIZER RECEIVES FDA APPROVAL FOR MYLOTARG™ (GEMTUZUMAB OZOGAMICIN) ONLY APPROVED ANTIBODY-DRUG CONJUGATE FOR NEWLY DIAGNOSED AND RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA REINTRODUCTION OF MYLOTARG SUPPORTED BY CONTINUED RESEARCH BY THE AML COMMUNITY DEMONSTRATING FAVORABLE RISK:BENEFIT PROFILE Friday, September 1, 2017 - 11:38am EDT Pfizer Inc. (NYSE:PFE) today...
Rye Brook, N.Y. (September 1, 2017) – The steady march of progress in new treatments for patients with acute myeloid leukemia (AML), one of the most deadly blood cancers which takes more than 10,000 lives in the U.S. each year, continues today with the U.S. Food & Drug...
First kinase inhibitor to show improvement in overall survival in any patient group with RAI-R DTC Data published in the Journal of Clinical Oncology WOODCLIFF LAKE, N.J., Aug. 28, 2017 /PRNewswire/ -- Eisai Inc. announced data from a prespecified subgroup analysis, which was published in the Journal of Clinical Oncology, showing treatment with...
On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval was based on data from INO-VATE ALL...
PFIZER RECEIVES U.S. FDA APPROVAL FOR BESPONSA® (INOTUZUMAB OZOGAMICIN) August 17, 2017 BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food...
CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion...
- New Therapy Demonstrated a Dramatic Improvement in Progression-Free Survival and a Statistically Significant Overall Response Rate in Some Patients with RAI-Refractory Differentiated Thyroid Cancer - File Submission and Approval Based on Data from Phase 3 SELECT Study Published in New England Journal of Medicine on...