Regulation or Law
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
SEC Staff Recommends Enforcement Action Against Allarity Over Potential Federal Securities Laws Violations
Allarity Therapeutics, SEC, Enforcement Action, Federal Securities Laws, Violations, Wells Notice, FDA, Dovitinib, Stenoparib
House Speaker Plans Vote on Biosecure Act Amid Broader China Legislation Push
House Speaker, Biosecure Act, China Legislation, National Security, Biotech Companies
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
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