The FDA on Tuesday accepted a new drug application from Shionogi to market ensitrelvir, an oral antiviral, as post-exposure ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ensitrelvir for the prevention of COVID-19 following exposure to an infected individual.

An announcement from Shionogi & Co ( ($JP:4507) ) is now available. Shionogi & Co., Ltd. announced that the FDA has accepted the New Drug ...

Moderna, Inc. today announced that it has submitted an application to the U.S. Food and Drug Administration for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1 ...

(Reuters) -Moderna said on Friday it has filed a marketing application for the review of its updated COVID-19 vaccine with the U.S. Food and Drug Administration. The company said the submission ...

AstraZeneca said on Monday that the European Union drug regulator has accepted a market authorisation application for its investigational COVID-19 prevention drug, sipavibart, for an accelerated ...

A spokesperson told POLITICO that the company has had discussions with the agency to maintain the authorization while it continues collecting data for a license application. A spokesperson for Moderna ...

New web-based application helps employers and hospital systems monitor the health of their employee populations during the COVID-19 pandemic.

Co-Diagnostics plans to submit an enhanced COVID-19 test for FDA clearance, addressing stability concerns and integrating platform advancements.

One of the major deficiencies was CBA Pharma failed to establish the drug’s efficacy for its intended use to enhance ...