Stephen Appezzato

FDA Commissioner Marty Makary resigns amid agency turmoil, staff exodus, pressure over vaccines, rulings on abortion pills, and vaping rules.

Tariff reimbursements may be requested through the US Customs and Border Protection’s online portal.

The FDA approves orforglipron (Foundayo), the first oral, non-peptide GLP-1 for obesity, the fastest NME approval under the new CNPV program.

The FDA's new era of proactive enforcement uses warnings to stop misleading GLP-1 ads and ensure a fair balance of drug risks and benefits.

FDA granted Hernexeos accelerated approval for 1st-line HER2-mutant NSCLC after a 44-day review via the National Priority Voucher Program.