Approved – Page 29

Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy

1 year 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

1 year 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

Bayer Acquires European Rights to BridgeBio’s Acoramidis for ATTR-CM Therapy

1 year ago talkbio0Tagged 2025, Acoramidis, Approved, ATTR-CM, Bayer, Blockbuster Potential, BridgeBio Pharma, Cardiovascular Infrastructure, Clarity, Clinical action, EMA Approval, European Rights, Exclusive License, Hope (emotion), investor, low-thirties, milestone payments, November 2024, PDUFA, Phase 3 Data, royalties, Split Strategy, Vyndaqel Rival

Bayer, BridgeBio Pharma, Acoramidis, ATTR-CM, Exclusive License, European Rights, Royalties, Milestone Payments, Phase 3 Data, Potential Approval, Low-Thirties Percent Royalties, EMA Approval 2025, PDUFA Action Date November 2024, Vyndaqel Rival, Blockbuster Potential, Cardiovascular Infrastructure, Investor Hopes for Clarity on Split Strategy.

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

1 year 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

1 year 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)

Sarepta shares PhII data for next-gen exon skipping drug, but regulatory pathway is unclear

1 year ago talkbio0Tagged Approved, Commission, Grail, next-generation exon-skipping drug, Regulatory Pathway, Sarepta's gene therapy, United States Food and Drug Administration

Regulatory Pathway, Sarepta, next-generation exon-skipping drug, United States Food and Drug Administration, Approved, Muscular Dystrophy, Duchenne, gene therapy, Sarepta’s gene therapy