Drug Approval | September 17, 2025
FDA approves Lupin’s Lenalidomide capsules
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use
ANVIMO will be available in dosages of 240 mg and 480 mg
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
DSP-5336, an Investigational Menin and Mixed-lineage Leukemia Inhibitor, is Being Evaluated in Patients with Relapsed or Refractory Acute Leukemia
225Ac-PSMA-Trillium is an investigational next-generation PSMA-targeted alpha therapy with potential to treat patients with advanced metastatic prostate cancer
Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients
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