FDA Accepts sNDA for INQOVI® Plus Venetoclax for Newly Diagnosed AML Patients Ineligible for Intensive ChemotherapyCombination therapy met primary efficacy endpoint with no new safety signals; would represent the first all-oral regimen for this patient population if approved Taiho Pharmaceutical…
FDA Approves Label Update for Lilly’s Alzheimer’s Drug Kisunla in Bid to Enhance Safety and Broaden Use The U.S. Food and Drug Administration (FDA) has approved a significant label update for Eli Lilly’s Alzheimer’s drug Kisunla, aimed at addressing persistent…
FDA Greenlights Label Update and Revised Dosing Schedule for Lilly’s Kisunla (donanemab‑azbt) in Early Symptomatic Alzheimer’s Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved an updated product label for Kisunla® (donanemab-azbt). This…
Global Sickle Cell Disease Treatment Market Poised for Robust Growth Through 2035 The global sickle cell disease (SCD) treatment market is set to witness substantial growth from 2025 to 2035, driven by increasing disease prevalence, advancements in therapeutic development, and…
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…