FDA Approves Gilead's Remdesivir as Coronavirus Treatment
Health
FDA Approves Gilead's Remdesivir as Coronavirus Treatment

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

FDA Releases High Coronavirus Vaccine Standards Despite White House Resistance
Health
FDA Releases High Coronavirus Vaccine Standards Despite White House Resistance

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

Fauci to FDA: ‘I Got Your Back’ on COVID-19 Vaccine Safety Standards
Health
Fauci to FDA: ‘I Got Your Back’ on COVID-19 Vaccine Safety Standards

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

FDA Blocks Much-Anticipated BioMarin Hemophilia Gene Therapy
Regulation
FDA Blocks Much-Anticipated BioMarin Hemophilia Gene Therapy

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

FDA Revokes Emergency Use of Hydroxychloroquine to Fight Coronavirus
Health
FDA Revokes Emergency Use of Hydroxychloroquine to Fight Coronavirus
2020-06-15 19:14:05
by Dan McCue

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

FDA Authorizes First At-Home Sample Collection Test for COVID-19
Health
FDA Authorizes First At-Home Sample Collection Test for COVID-19
2020-04-21 20:40:19
by Dan McCue

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

FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus
Courts
FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus

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

FDA Issues Emergency Approval for Coronavirus Test
In The News
FDA Issues Emergency Approval for Coronavirus Test

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

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