Governmental or Regulatory Activity
FDA Postpones Opioids Advisory Committee Meeting and Cancels Kidney Drug Review
FDA, advisory committee, postponement, cancellation, opioids, kidney drug, regulatory meetings
FDA Delays Decision on Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Until April 2025
Barth Syndrome, Elamipretide, FDA Decision, Stealth BioTherapeutics, Drug Approval Delay
Trump Revokes Biden’s Executive Order on AI Safety and Trustworthiness
AI Safety, Biden Executive Order, Trump Administration, Artificial Intelligence Governance, AI Regulation
InnoCare and KeyMed Secure $520M Licensing Deal for Bispecific Antibody with RTW-Built Biotech
InnoCare, KeyMed, Bispecific Antibody, RTW Investments, Licensing Deal, $520M
Medicare Selects Ozempic, Wegovy for Price Negotiations: A Step Towards Lowering Prescription Drug Costs
Medicare, drug price negotiations, Ozempic, Wegovy, Inflation Reduction Act, prescription drug costs, seniors, healthcare.
Understanding the Second Round of Medicare Drug Price Negotiations: What Trump’s CMS Can and Can’t Change
Medicare drug price negotiation, Trump administration, CMS, Inflation Reduction Act, drug prices, negotiation process
Appeals Court Upholds FDA’s Denial of Fast Track Designation for Vanda’s Gastroparesis Drug
FDA, Vanda Pharmaceuticals, Fast Track Designation, Gastroparesis, Drug Approval Process
FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025
FDA, AI, drug approval, guidance, regulatory decision-making, medical devices, artificial intelligence, drug development
FDA Advisory Panels: Activity Levels Normalize After 2023 Surge
FDA advisory panels, adcomms, regulatory changes, advisory committee meetings
Healthcare Sector Winners and Losers in the 2024 Government Funding Bill
Healthcare funding, government shutdown, telehealth, Medicare payments, Medicaid DSH, hospital-at-home programs, physician pay cuts, healthcare legislation.