FDA
The U.S. Food and Drug Administration has officially approved remdesivir as a treatment for coronavirus, drug manufacturer Gilead Sciences announced Thursday. The Ebola drug was already being used to treat patients under an emergency-use authorization issued in May, but the latest FDA action makes... Read More
WASHINGTON — The Food and Drug Administration issued long-awaited guidance Tuesday on the data it expects from drug companies seeking emergency authorization of COVID-19 vaccines, rejecting White House pressure for lower standards intended to push out vaccines quickly. The 18-page... Read More
ATLANTA — The federal government’s top infectious disease official attempted to reassure the public Thursday that he’ll support safety standards set by federal officials for any COVID-19 vaccines and their work won’t be swayed by politics. “If (U.S. Food and... Read More
FAIRLESS HILLS, PA (AP) — Investors fled drug developer BioMarin in droves on Wednesday, driving shares down by a third after U.S. regulators rejected the company’s potentially game-changing hemophilia A gene therapy over concerns it might not really be a... Read More
WASHINGTON - The Food and Drug Administration revoked its emergency authorization of hydroxychloroquine and chloroquine for treating COVID-19 as evidence mounts that the drugs don't work and can cause serious side effects. “We’ve made clear throughout the public health emergency... Read More
WASHINGTON - The Food and Drug Administration Tuesday approved the first diagnostic test for the coronavirus that allows people to collect their sample at home -- a development that could greatly expand testing options in states fighting to corral the... Read More
WASHINGTON — The Food and Drug Administration asked a federal judge to grant a 120-day delay for a deadline for e-cigarette manufacturers to submit applications to keep their products on the market. Citing “the exceptional circumstances presented by the global... Read More
The federal government has issued an emergency order allowing its coronavirus test to be used by state health labs nationwide, speeding up efforts to detect and contain new cases of the mysterious new illness. Since the first cases of the... Read More
