HHS: All Branded Drugs Without Generic or Biosimilar Competition Must Abide by MFN Order Across All Markets

most-favored nation pricing; branded drugs; generic competition; biosimilar competition; HHS; executive order; drug pricing; pharmaceutical industry; OECD countries

Pharma Companies Eye ‘First Sale’ Rule to Lessen Tariff Costs Amid New US Trade Measures

first sale rule; pharmaceutical industry; US tariffs; customs loophole; drug import duties; tariff avoidance; trade compliance; Trump administration; de minimis exemption

FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo

FDA; advisory committee; Pfizer; Talzenna; talazoparib; enzalutamide; prostate cancer; mCRPC; PARP inhibitor; label expansion; unanimous vote

Moderna Shares Fall as Company Withdraws Flu/COVID-19 Combination Vaccine Application

Moderna; mRNA-1083; combination vaccine; flu; COVID-19; FDA; Biologics License Application; vaccine efficacy; clinical trial; share price

FDA Advisory Committee Narrowly Votes Against UroGen’s Bladder Cancer Drug, Calls for Further Studies

FDA; UroGen Pharma; UGN-102; bladder cancer; Oncologic Drugs Advisory Committee; mitomycin; RCT; non–muscle invasive bladder cancer; clinical trials