Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration recently issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe …
FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted Read More
RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that the US Food and Drug Administration (FDA) recently declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil) for a sub-group …
FDA Declines Emergency Use Authorization for ZYESAMI Read More
MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) recently announced that the U.S. Food and Drug Administration (FDA), at this time, has declined to issue an EUA for COVAXIN™ for active …
Ocugen Provides an Update on its COVAXI Pediatric (2-18) Emergency Use Authorization Request Read More RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) announced that it recently submitted an application for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for the use …
NRx Pharmaceuticals Submits Emergency Use Authorization Application to FDA for ZYESAMI to Treat Patients at Immediate Risk of Death from COVID-19 Read More
WASHINGTON, D.C. — The Biden-Harris Administration this week authorized two new over-the-counter, at-home COVID-19 tests to the U.S. market. The tests, one manufactured by SD Biosensor and distributed by Roche and …
Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S. Market Read More
HARRISBURG, PA — Governor Tom Wolf recently issued a statement on the U.S. Food and Drug Administration’s (FDA) full approval of the Pfizer BioNTech COVID-19 vaccine for individuals 16 and older:
Gov. Wolf: FDA Approval Solidifies Safety and Efficacy of COVID-19 Pfizer BioNTech Vaccine Read More
WASHINGTON, D.C. — This week, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow …
FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration recently issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults …
FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19 Read More MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the U.S. Food & Drug Administration (FDA) in …
ChesCo-based Biopharmaceutical Company to Submit COVID-19 Vaccine Candidate for Emergency Use Authorization Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the …
FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab Read More