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The new CHMP recommendations are expected to enable the production of an additional “one to two million vials” of vaccine for the EU market each month, the committee said. Read More
The FDA would need to see safety data from at least 3,000 trial participants to grant Emergency Use Authorization or approval for a COVID-19 vaccine for children under age 12, an agency official told members of its vaccine advisory panel yesterday. Read More
The test can be used for patients who do not have any symptoms or suspected COVID-19 infection. A nondirect-to-consumer version of the test was authorized earlier this year. Read More
The U.S. government will pay Merck an estimated $1.2 billion for 1.7 million courses of its experimental COVID-19 antiviral, molnupiravir, if the drug is authorized by the FDA. Read More
Regeneron Pharmaceuticals has received an updated Emergency Use Authorization (EUA) from the FDA for a lower dosage of its COVID-19 antibody cocktail, REGEN-COV (casirivimab/imdevimab). Read More
Moderna has struck a fill-and-finish deal with Thermo Fisher Scientific to produce hundreds of millions of doses of Moderna’s messenger RNA-based COVID-19 vaccine at its Greenville, N.C., plant. Read More
Moderna has begun its bid for full U.S. approval for its COVID-19 vaccine in the hopes of advancing it beyond Emergency Use Authorization (EUA) status. If regulators grant the request, it will allow the company to market the vaccine directly to consumers and would mark Moderna’s first approved product for the coronavirus. Read More
World Trade Organization (WTO) negotiations resumed Monday over a revised version of a controversial proposal to temporarily waive patents for COVID-19 products, including vaccines and therapeutics. Read More
In early May, the World Health Organization listed one of Sinopharm’s COVID-19 vaccines for emergency use, clearing the way for its global distribution through the Covax initiative. Read More