regulatory
FDA Establishes AI Council to Oversee Ongoing and Future AI Projects
FDA, AI Council, Digital Health Advisory Committee, Artificial Intelligence, Machine Learning, Regulatory Guidance
The Post-Chevron Regulatory Landscape: Implications for the FDA and Healthcare Industry
Chevron deference, FDA, regulatory landscape, healthcare industry, Supreme Court ruling, Loper Bright Enterprises v. Raimondo, Corner Post, Inc. v. Board of Governors of the Federal Reserve System, Administrative Procedure Act (APA), judicial scrutiny, legal challenges, regulatory implications.
Navigating Challenges and Opportunities in the 2024 Life Sciences Industry Outlook
Life Sciences Industry, 2024 Outlook, Biotechnology, Medical Devices, Artificial Intelligence, Drug Pricing, Regulatory Changes, Supply Chain Security, Talent Shortage
Novo Nordisk Withdraws FDA Submission for Wegovy’s Heart Failure Indication, Plans to Reapply Next Year
Novo Nordisk, Wegovy, FDA submission, heart failure, label expansion, regulatory delay
Supreme Court Overturns Chevron Doctrine, Limiting FDA’s Regulatory Authority
Chevron doctrine, FDA, regulatory authority, Supreme Court, administrative law, agency interpretations, statutory ambiguity
Innovent to Submit IL-23 Psoriasis Drug to Chinese Regulators Following Phase 3 Success
Innovent, IL-23, psoriasis, picankibart, phase 3, China, regulatory submission, plaque psoriasis, CLEAR-1 study
Novartis Achieves Success in Two Phase III Trials for Rare Kidney Diseases, Eyes Regulatory Submissions
Novartis, Phase III trials, Rare kidney diseases, IgA nephropathy, C3 glomerulopathy, Regulatory submissions
FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request
FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.
Revolutionizing Healthcare: Streamlining Cell and Gene Therapy Manufacturing (Part 1)
Cell therapy, gene therapy, manufacturing, biotechnology, healthcare innovation, personalized medicine, production challenges, regulatory compliance, scalability, cost-effectiveness.
Revolutionizing Medicine: The Evolution and Future of Cell and Gene Therapy Manufacturing
Cell therapy manufacturing, gene therapy manufacturing, biomanufacturing, advanced therapies, CAR-T cell therapy, stem cell therapy, viral vectors, bioreactors, automation, scale-up, regulatory compliance, personalized medicine.