Senate Drops Orphan Cures Act from Trump’s Tax Bill, Dealing Setback to Biopharma

Orphan Cures Act; orphan drugs; Trump tax bill; biopharma; Senate; IRA price negotiations; rare diseases; Big Beautiful Bill; healthcare legislation; reconciliation bill

FDA Launches New Priority Review Voucher Program Aligned with National Priorities

FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs

New Rules and Regulatory Trends in Biopharma Manufacturing in 2025

biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization