InnoCare Secures IND Approval in China for B7-H3-Targeted ADC ICP-B794 to Advance Solid Tumor Therapies InnoCare Pharma a leading biopharmaceutical company dedicated to developing innovative treatments for cancer and autoimmune diseases, announced the recent approval of its Investigational New Drug…
Biotech Executives and Investors Urge FDA to Preserve Access to Mifepristone Amid Legal Uncertainty A group of leading biotechnology executives, investors, and scientific experts are urging the U.S. Food and Drug Administration (FDA) to safeguard continued access to mifepristone, a…
Regeneron Secures FDA Accelerated Approval for Lynozyfic in Multiple Myeloma, Eyes Differentiation Despite Market Head Start by Rivals In a bid to strengthen its oncology portfolio, Regeneron Pharmaceuticals announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted…
Regeneron’s Lynozyfic™ Secures FDA Accelerated Approval for Heavily Pretreated Multiple Myeloma Patients Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) for the treatment of adult patients with…
FDA Grants Accelerated Approval to Regeneron’s Lynozyfic™ (linvoseltamab-gcpt) for Relapsed or Refractory Multiple Myeloma Regeneron Pharmaceuticals has secured a critical milestone in oncology drug development with the U.S. Food and Drug Administration’s (FDA) accelerated approval of Lynozyfic™ (linvoseltamab-gcpt), a first-in-class…
FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. and Canada, has announced a significant regulatory milestone for…
Jazz Pharmaceuticals Secures Conditional EU Approval for Ziihera® (zanidatamab) to Treat Advanced HER2-Positive Biliary Tract Cancer Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has announced that the European Commission (EC) has granted conditional marketing authorization for Ziihera® (zanidatamab), a dual HER2-targeted bispecific…
Takeda Secures FDA Approval for GAMMAGARD LIQUID ERC, the First Ready-to-Use Liquid Immunoglobulin Therapy with Low IgA Content Takeda (TSE:4502/NYSE:TAK) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for GAMMAGARD LIQUID ERC [immune globulin infusion…
Vertex Gains EU Approval for ALYFTREK®, a Next-Generation CFTR Modulator for Cystic Fibrosis Patients Vertex Pharmaceuticals (Nasdaq: VRTX) announced today that the European Commission has granted marketing authorization for ALYFTREK® (deutivacaftor/tezacaftor/vanzacaftor), a new, once-daily triple-combination CFTR modulator therapy for the…
FDA Accepts Allergan’s Application to Expand SKINVIVE by JUVÉDERM® for Neck Line Treatment Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental premarket approval (sPMA) application for SKINVIVE by…
Global pharmaceutical major Lupin Limited announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. These tablets are the generic…
Teva and Alvotech Expand U.S. Biosimilar Portfolio with Approval for SELARSDI™ Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) have announced that the U.S. Food and Drug Administration (FDA) has…
