Chester County News and Community Website
WASHINGTON, D..C. — The U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) on July 06, 2022, to authorize state-licensed pharmacists to prescribe …
FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration recently expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing …
FDA Approves First COVID-19 Treatment for Young Children Read More
WASHINGTON, D.C. — U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra recently announced that the federal government has purchased 600,000 treatment courses of a new monoclonal antibody …
HHS Announces Purchase of 600,000 Treatment Courses of New Monoclonal Antibody That Works Against Omicron Read More
WASHINGTON, D.C. — On Friday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against …
FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 Read More
WASHINGTON, D.C. — The following is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research:
FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has taken two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients …
FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 Read More
RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) announced that it recently filed a new Breakthrough Therapy Designation (BTD) request with the US Food and Drug Administration (FDA) focused on patients …
NRx Pharmaceuticals Files Breakthrough Therapy Designation Request for ZYESAMI Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive …
FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of …
FDA Authorizes First Oral Antiviral for Treatment of COVID-19 Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration recently revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older …
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns Read More