The U.S. Food and Drug Administration (FDA) has approved Celcuity’s REVTORPYK (gedatolisib) for the treatment of HR+/HER2- metastatic breast cancer patients who do not possess a PIK3CA mutation. As the first therapy capable of inhibiting all class I PI3K isoforms (α, β, δ, γ) in conjunction with both mTORC1 and mTORC2 complexes, REVTORPYK introduces a novel mechanism of action for a patient population that accounts for approximately 42% of all HR+/HER2- diagnoses. Also read:

The Centers for Medicare & Medicaid Services (CMS) has introduced a broad regulatory proposal aimed at restructuring Medicare physician payments and accelerating the transition toward value-based care. The initiative centers on four strategic objectives: Broadening participation in accountable care models Refining payment methodologies Streamlining administrative operations Prioritizing proactive preventative medicine over traditional reactive healthcare delivery Key Regulato