RAHWAY, N.J. — Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients...
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TOKYO & BASKING RIDGE, N.J. — Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/NYSE: AZN) supplemental Biologics License Application (sBLA) for DATROWAY® (datopotamab deruxtecan-dlnk) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are...
SPRING HOUSE, Pa. — Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY® (nipocalimab-aahu),c confirming the urgent need for treatment options in warm autoimmune hemolytic anemia (wAIHA). Priority Review is granted to medicines...
BRIDGEWATER, N.J. — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Supplemental New Drug Application (sNDA) for review of ARIKAYCE® (amikacin...
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...
Basel, Switzeraland – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED). The filing acceptance is based on results...
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...