regulatory
Sanofi Prepares for Regulatory Submission of Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis
Tolebrutinib, BTK inhibitor, Multiple sclerosis, Non-relapsing secondary progressive multiple sclerosis (nrSPMS), Sanofi, HERCULES study, GEMINI 1 and 2 studies, Regulatory approval
FDA Enhances Transparency in Drug Review Process with Revised Document Structure
FDA, drug review process, transparency, document structure, regulatory oversight
FDA Updates Guidance to Combat Online Misinformation About Medical Products
FDA, online misinformation, medical products, guidance, regulatory clarity, public health
Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Paving Way for Regulatory Filings
Gilead Sciences, Lenacapavir, HIV Prevention, Twice-Yearly PrEP, Regulatory Filings, PURPOSE 2 Trial
Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Eyes 2025 Launch for HIV Prevention
Lenacapavir, HIV Prevention, Twice-Yearly Injection, Gilead Sciences, PrEP, PURPOSE 1 and 2 Trials, Regulatory Filings, 2025 Launch
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