Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for CELGENE CORP's drug REBLOZYL (SUPPL-10) with active ingredient LUSPATERCEPT-AAMT has changed to 'Approval' on 05/16/2024. Application Category: BLA, Application Number: 761136, Application Classification:
Submission status for CELGENE CORP's drug REBLOZYL (SUPPL-9) with active ingredient LUSPATERCEPT-AAMT has changed to 'Approval' on 08/28/2023. Application Category: BLA, Application Number: 761136, Application Classification:
Submission status for CELGENE CORP's drug REBLOZYL (SUPPL-6) with active ingredient LUSPATERCEPT-AAMT has changed to 'Approval' on 07/08/2022. Application Category: BLA, Application Number: 761136, Application Classification:
Submission status for CELGENE CORP's drug IDHIFA (SUPPL-5) with active ingredient ENASIDENIB MESYLATE has changed to 'Approval' on 07/26/2021. Application Category: NDA, Application Number: 209606, Application Classification: Manufacturing (CMC)
For Immediate Release: March 27, 2021 The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. “The FDA remains committed to ad
Fastest customizable press release news feed in the world
SOUTH SAN FRANCISCO, Calif., Dec. 1, 2020 /PRNewswire/ -- Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, today announced that Jon M. Wigginton, M.D., has been appointed to Sutro's Board of Directors. "As a seasoned global pharmaceutical leader with a passion for drug development and expertise in oncology, Jon brings a wealth of experience to the Board," said Bill Newell, Sutro's Chief Executive Officer. "His impressive successes in leading programs and bridging basic science, translational