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03 Dec

Posted at 20:00h in News
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CAMBRIDGE, Mass., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company with a validated scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases, today announced a revised regulatory strategy in the United States for M923, Momenta’s proposed biosimilar to HUMIRA. Momenta had...

25 Oct

Posted at 20:29h in News
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Eisai Launches Anticancer Agent Lenvima® (Lenvatinib Mesylate) In United Kingdom Indicated For Advanced Thyroid Cancer Refractory To Radioactive Iodine Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Ltd. has launched its in-house developed novel anticancer agent Lenvima®...

27 Sep

Posted at 20:32h in News
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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...

02 May

Posted at 20:33h in News
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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...

01 Nov

Posted at 19:56h in News
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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...

01 Sep

Posted at 20:34h in News
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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...

28 Aug

Posted at 12:43h in News
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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...

07 Aug

Posted at 20:35h in News
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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...