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Amylyx’s ALS Treatment Relyvrio Disappoints in Phase III PHOENIX Study, Company Considering Market Withdrawal
Amylyx, Relyvrio, ALS, Failure, Phase III PHOENIX Study, Market Withdrawal, Clinical Trial, Placebo, No Statistical Significance
BeiGene Scores Two Major FDA Approvals – Trivimbra for Esophageal Cancer and Brukinsa for Follicular Lymphoma
BeiGene, Trivimbra (tislelizumab), Esophageal Cancer, Brukinsa (zanubrutinib), Follicular Lymphoma, FDA Approval, Accelerated Approval, Obinutuzumab
Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy
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
“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”
ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy
Minerva’s Roluperidone for Schizophrenia Symptoms Denied Approval by FDA
United States Food and Drug Administration, MFSD1 gene, Symptoms aspect, Schizophrenia, New Drug Application
Minerva Entangles in Web of FDA Rejection Again Over Schizophrenia Drug Roluperidone
United States Food and Drug Administration, MFSD1 gene, Schizophrenia
Venatorx Confident in Quick Resolution of Manufacturing Concerns for Cefepime-Taniborbactum Antibiotic Despite FDA Setback
United States Food and Drug Administration, Venatorx, CID, 2024-02-23, cefepime-taniborbactam, Manufacture
Improving Amylyx’s ALS Drug Relyvrio: Taste Masking and Withdrawal
Amylyx, ALS, Relyvrio, Taste Masking, Withdrawal, Patent Life