As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron ...

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

The Pfizer/BioNTech bivalent COVID-19 vaccine (Original and Omicron BA.4/BA.5) has the FDA’s EUA for use in individuals 5 years and over as a single booster dose administered at least two months ...

S hares of Invivyd (NASDAQ:IVVD) closed 42% higher Friday after the biotech company announced it had received FDA emergency use authorization, or EUA, for its COVID-19 prophylactic drug Pemgarda ...

Concerns about the COVID-19 shots have increased after a report that drug maker Moderna failed to inform the U.S. government ...

This update is based on a press release statement from Invivyd, Inc. The company's stock has experienced significant volatility, with a 16.39% gain in the past week despite a 64.17% decline over six ...

(RTTNews) - Invivyd, Inc. (IVVD), a biopharmaceutical company, on Monday announced the submission of an updated immunobridging analysis to the U.S. Food and Drug Administration or FDA in support ...

Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart,” the FDA document went on. “Based on results from the clinical trial ...

Invivyd (IVVD) announced the submission to the U.S. Food and Drug Administration, FDA, of an updated immunobridging analysis of pemivibart as ...

Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode ® SARS-CoV-2 Flu Plus Assayⱡ, BioCode® SARS-CoV-2 Assay*, and an additional ...