Governmental or Regulatory Activity
FDA Approves Apple Watch’s Afib-Tracking App for Clinical Research
Apple Watch, afib-tracking app, FDA certification, clinical studies, heart health, medical technology, wearable devices, digital health.
Revolutionizing Public Health: CBER’s Peter Marks and the Vision to Reduce FDA Visits
CBER, Peter Marks, FDA, public health, healthcare innovation, regulatory affairs, biologics, vaccines, medical devices, preventive measures.
Lykos Therapeutics’ MDMA-Assisted Therapy for PTSD: Awaiting FDA Advisory Committee Review
Lykos Therapeutics, MDMA-assisted therapy, PTSD treatment, FDA Advisory Committee, clinical trials, drug approval process.
FDA Approval Milestones: X4 Pharmaceuticals, Pfizer, and Genmab Secure Nods for Rare Disease and Cervical Cancer Treatments
FDA, X4 Pharmaceuticals, Pfizer, Genmab, rare disease, cervical cancer, drug approval, treatment, healthcare, biotechnology.
Medicare Coverage Gap Linked to Reduced Prescription Rates for GLP-1 Weight Loss Drugs
GLP-1 drugs, Medicare coverage gap, Lower prescription rates, Obesity treatment, Semaglutide (Wegovy), Tirzepatide (Mounjaro), Liraglutide (Saxenda), Healthcare costs, Truveta study
Medicare Partially Covers Weight Loss Drugs Amidst High Price Concerns and Future Negotiation Prospects
Medicare, Obesity drugs, Wegovy, Semaglutide, Price negotiation, Affordability, Accessibility, Premium increases, Utilization management
Biden Ramps Up Fight Against High Drug Prices in State of the Union Address
State of the Union Address, Biden Administration, Big Pharma, Drug Prices, Inflation Reduction Act, Medicare Drug Negotiations, Out-of-Pocket Cap Expansion, Private Insurance Protections, Generic Drug Cost-Sharing Limit, Cell & Gene Therapy Access Model, Commercial Drug Sales Rebates
Biden Proposes Expansion of Medicare Drug Price Negotiation Program
Biden, Medicare, Drug Prices, Negotiation, Increased Scrutiny, More Drugs, Health Care Policy