Clinical Trials
FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients
FDA approval, Idorsia, Aprocitentan, Tryvio, Resistant hypertension, Endothelin receptor antagonist, Systolic blood pressure, Uncontrolled hypertension, Combination therapy, Clinical trials, PRECISION study, Recommended dosage: 12.5 mg, Availability: Second half of 2024, Edema and fluid retention side effects
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.
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
Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks
Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies
Merck KGaA Abandons BTK Inhibitor Program, Emphasizes External Innovation
Merck KGaA, BTK inhibitor, Evobrutinib, External innovation strategy, Failed clinical trials
“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
Lilly reports mid-stage win for tirzepatide in fatty liver disease
tirzepatide, Nonalcoholic Steatohepatitis, liver scarring, Lilly reports, MASH, Clinical Trials