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The Food and Drug Administration has authorized Juul's original vaporizer and flavored cartridges to remain on the U.S. market.
The FDA issued an emergency use authorization to drug-maker Lilly for bamlanivimab, a monoclonal antibody that mimics the immune system’s response to infection with the virus that causes COVID-19.
Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use ...
The emergency use authorization continues until the health secretary ends it. Existing product authorizations can continue, and new ones, such as the updated COVID-19 vaccines, can be issued as ...
Pemgarda, made by Invivyd, is an infusion drug approved for use by patients who are immunocompromised to help protect against COVID-19 infection.
It is a protein-based vaccine, and such vaccines use harmless protein fragments of the virus to teach the immune system how to spot the virus and fight it off.
Moderna is seeking emergency use authorization from the US Food and Drug Administration for its Covid-19 vaccine for children 6 months through 5 years of age, the company said Thursday.
In December, the company said it had finished its final submission package to the FDA for emergency use authorization of the vaccine, called NVX-CoV2373.
Novavax asked the Food and Drug Administration on Monday to grant an emergency use authorization for its protein-based COVID-19 vaccine.
The CEO and President of Merck, Robert M. Davis, said, “The FDA Emergency Use Authorization of molnupiravir is an important milestone in the fight against COVID-19, and adds to Merck’s legacy ...
A Food and Drug Administration advisory panel on Tuesday voted to endorse emergency use authorization for Merck's experimental COVID-19 pill.