United States Food and Drug Administration – Page 84

Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy

2 years ago talkbio0Tagged Accelerated, Approved, broadest label, Brukinsa, BTK Inhibitor, CHMP, Chronic lymphoma, Combined Modality Therapy, Lymphoma, Follicular, obinutuzumab, Oregon (geographic location), Overall response rate, Phase 2 Clinical Trials, Phase II ROSEWOOD trial, Recommendation, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Relapsing course, Rosewood, United States Food and Drug Administration

Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR

Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy

2 years ago talkbio0Tagged amgen, Approved, Biosimilars, Cancer-related skeletal events, denosumab, interchangeable, Jubbonti, Osteoporosis, patent litigation, Prolia, sandoz, Secondary malignant neoplasm of bone, United States Food and Drug Administration, Wyost, Xgeva

Sandoz, FDA approval, Denosumab biosimilars, Wyost, Jubbonti, Interchangeable, Prolia, Xgeva, Amgen, Osteoporosis, Bone metastases, Cancer-related skeletal events, Patent litigation

“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”

2 years ago talkbio0Tagged Amyotrophic Lateral Sclerosis, Antisense Therapy, Approved, Clinical Trials, masitinib, Patient advocacy, regulatory uncertainty, Relyvrio, risk-benefit analysis, United States Food and Drug Administration

ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy

J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations

2 years ago talkbio0Tagged amivantamab-vmjw, Approved, carboplatin-pemetrexed chemotherapy, Disease Progression, EGFR Exon 20, first-line, Insertion Mutation, Johnson and Johnson, Mortality Risk, Non-Small Cell Lung Carcinoma, Objective Response Rate, ORR, Progression-Free Survival, Reduced, Rybrevant, United States Food and Drug Administration

Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)