Shares of Provention Bio Inc. plunged in trading after a Food and Drug Administration advisory committee narrowly supported the company’s diabetes prevention drug, teplizumab.
U.S. FDA Approves Abecma for Relapsed or Refractory Multiple MyelomaApprovals, B-cell maturation antigen (BCMA), Bristol Myers Squibb, CAR-T Therapy, Clinical Trials, Cytokine Release Syndrome (CRS), FDA/Regulatory, First-In-Class, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Proteasome Inhibitors, R&D, Relapse/Refractory Multiple Myeloma, Therapeutics
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel) as the first anti-BCMA CAR T cell therapy for relapsed or refractory multiple myeloma.
FDA Approves Oncopeptides’ Pepaxto for Triple-Class Refractory Multiple MyelomaApprovals, Brands, Clinical Trials, Dexamethasone, FDA, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Product Launches, Proteasome Inhibitors, R&D, Steroids, Therapeutics, Triple-Class Refractory Multiple Myeloma
The U.S. Food and Drug Administration approved Oncopeptides AB’s Pepaxto (melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Top 200 Medicines Annual Report: Climbing Mount HumiraAnalysts, August 2020, Autoimmune Diseases, Biologics, Blockbusters, Checkpoint Inhibitors, Chemotherapy, FDA, Healthcare Physicians, Human Anti-CD38 Monoclonal Antibody, Immuno-oncology, Issue Archives, Med Ad News, Metastatic squamous cell carcinoma of the esophagus, Multiple myeloma, Oncology, PD-1/PD-L1 inhibitors, Therapeutics, Top 200 Medicines
While Humira remains the best-selling prescription product worldwide, Keytruda has risen to the No. 2 global rank and is on track to eventually claim the top spot.
Paris-based Sanofi and Houston-based The University of Texas MD Anderson Cancer Center entered a five-year strategic partnership to develop immune therapies and targeted cancer treatments.
Kiadis Pharma licensed a previously undisclosed K-NK0004 program to Sanofi covering Kiadis’ proprietary CD38 knock out (CD38KO) K-NK therapeutics for combination with anti-CD38 monoclonal antibodies.
DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple MyelomaAccelerated Drug Approvals, Approvals, Biotech, Biotechnology, Blood Cancers, Breakthrough Designation, Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Clinical Trials, FDA/Regulatory, First-In-Class, Health, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Immunotherapy, Launches, Monoclonal Antibodies, Monoclonal Antibodies, Multiple Myeloma, Multiple Myeloma, Multiple Myeloma, New Drug Approvals, Priority Review, Priority Review, Product Launches, Proteasome Inhibitors, R&D
First-in-class immunotherapy approved for multiple myeloma patients who have received three or more prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who […]