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Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is characterized by atypical overgrowths and anomalies in blood vessels, the lymphatic system and other tissues2,3   Approval based on real-world data from EPIK-P1 study, [...]

-- First LBCL Treatment to Improve Upon Standard of Care in Nearly 30 Years -- -- Landmark ZUMA-7 Study Demonstrated Patients on Yescarta Were 2.5 Times More Likely to Be Alive at Two Years Without Cancer Progression or Need for Additional Cancer Treatment -- -- Yescarta is First CAR T-cell Therapy to Receive NCCN Treatment [...]

Ad hoc announcement pursuant to Art. 53 LR FDAalsoapprovedcomplementarydiagnosticimagingagent,Locametz®,after radiolabeling with gallium-68 for the identification of PSMA-positive lesions2 Metastaticprostatecancerhasa5-yearsurvivalrateoflessthan30%3;mCRPC patients who progress on multiple lines of therapy have limited treatment options FDAapprovalwasbasedonpivotalPhaseIIIVISIONtrial,wherepatientswithpre- treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints [...]

Based on KEYNOTE-158 Trial, Patients Receiving KEYTRUDA Demonstrated an Objective Response Rate of 46% Approval Marks Fourth Gynecologic Cancer Indication for KEYTRUDA KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a [...]

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab1 In RELATIVITY-047, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy, an established standard of care1,2 Relatlimab is the third immune checkpoint inhibitor from Bristol Myers Squibb, adding to the Company’s growing and differentiated oncology portfolio [...]

First and only approved medicine targeting BRCA mutations in early breast cancer New data show Lynparza demonstrated overall survival benefit in early breast cancer     AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the US for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already [...]

- VONJO is the First Approved Therapy to Specifically Address the Needs of Adult Cytopenic Myelofibrosis Patients -- NDA Approved Under Priority Review -- Approval Triggers $60 Million Payment from DRI Healthcare Trust -- CTI to Host Conference Call Tomorrow at 8:00 a.m. ET - SEATTLE, Feb. 28, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) [...]

Approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer1 In the Phase 3 CheckMate -816 trial, Opdivo plus platinum-doublet chemotherapy significantly improved event-free survival and pathologic complete response compared to platinum-doublet chemotherapy alone1 Opdivo-based combinations now approved in both metastatic and earlier stages of non-small cell lung cancer PRINCETON, [...]

In the pivotal clinical study, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 78 percent of patients who responded experienced a stringent complete response HORSHAM, Pa., February 28, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and [...]