PRINCETON, N.J. — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi® (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines...
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RAHWAY, N.J. – Merck & Co. (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of...
SAN CARLOS, Calif. – BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients...
SOUTH SAN FRANCISCO, Calif. — Genentech, Inc. a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with...
Mechelen, Belgium – Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the U.S. Food and Drug Administration (FDA) has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL). The RMAT designation was established under the U.S....
HOUSTON, Texas — March Biosciences (March Bio), a clinical stage biotechnology company developing cell therapies for hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-105, the Company’s first-in-class autologous CD5-targeted CAR-T cell therapy, in development for relapsed/refractory CD5-positive T-cell...
GUILDFORD, England, May 15, 2023 (GLOBE NEWSWIRE) — SiSaf Ltd, an RNA delivery and therapeutics company, announces that SIS-101-ADO, its siRNA therapeutic for patients with Autosomal Dominant Osteopetrosis Type 2 (ADO2), has been granted Orphan Drug Designation by the U.S. FDA. In addition, due to the serious manifestations of this...
PRINCETON, N.J. — Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation...
PRINCETON, NJ – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration...
THOUSAND OAKS, Calif. – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The FDA grants Priority...