Danish drugmaker Novo Nordisk won FDA approval Thursday for a higher dose of its weight-loss drug Wegovy — a decision FDA ...

WASHINGTON — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, ...

The FDA made waves with its recent announcement that a single well-controlled Phase 3 study would suffice for a drug submission, replacing the previous standard of two pivotal studies. This past week, ...

WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, the latest change from Trump administration ...