Functional Concept
Roche’s TIGIT Drug Tiragolumab Fails Another Phase 3 Lung Cancer Trial
Roche, TIGIT, tiragolumab, lung cancer, Phase 3 trial, failure, Keytruda, Tecentriq
Medicare Drug Price Negotiation Program Upheld in Court, Defeating Boehringer Ingelheim’s Challenge
Medicare, drug pricing, negotiation program, Boehringer Ingelheim, legal challenge, pharmaceutical industry, healthcare policy
FDA Approves Eli Lilly’s Alzheimer’s Drug Donanemab, Offering New Treatment Option
Alzheimer’s disease, Eli Lilly, FDA approval, donanemab, Kisunla, anti-amyloid monoclonal antibody, cognitive decline, amyloid plaques, treatment options
Moderna Secures $176 Million BARDA Award for Bird Flu Vaccine Development
Moderna, BARDA, Bird Flu, Vaccine Development, mRNA Technology, Pandemic Preparedness
Supreme Court Overturns Chevron Doctrine, Limiting FDA’s Regulatory Authority
Chevron doctrine, FDA, regulatory authority, Supreme Court, administrative law, agency interpretations, statutory ambiguity
Savara Raises $100 Million Following Lung Disease Treatment Breakthrough
Savara, Lung Disease, $100 Million Raise, Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Treatment
FDA Rejects Merck-Daiichi’s HER3-Targeted ADC Due to Manufacturing Issues
FDA, Merck, Daiichi Sankyo, HER3-targeted ADC, patritumab deruxtecan, manufacturing concerns, lung cancer treatment
FDA Approves EPKINLY (Epcoritamab-Bysp) for Relapsed or Refractory Follicular Lymphoma
EPKINLY, epcoritamab-bysp, follicular lymphoma, FDA approval, relapsed or refractory, bispecific antibody, T-cell engaging, subcutaneous treatment
Sarepta Therapeutics: Next Steps After Full FDA Approval for Duchenne Muscular Dystrophy Gene Therapy
Sarepta Therapeutics, Duchenne muscular dystrophy, gene therapy, FDA approval, Elevidys, microdystrophin, ambulatory patients, non-ambulatory patients, pipeline development, rare diseases, genetic medicine.
Wave Life Sciences Achieves Breakthrough in Huntington’s Disease Treatment with WVE-003, Eyes Accelerated Approval
Wave Life Sciences, Huntington’s disease, WVE-003, Phase Ib/IIa study, accelerated approval, mutant huntingtin protein, allele-selective silencing, RNA medicine