Food and Drug Administration (FDA)
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Thirty-five members of the Bloomberg New Economy International Cancer Coalition issued a call for a permanent change to the way cancer is diagnosed and treated around the world.
Orasis Pharmaceuticals announced that its eye drop candidate CSF-1 met all primary and key secondary endpoints in Phase III clinical trials. CSF-1 is intended to treat presbyopia.
Moderna is poised to seek the regulatory authorization of its COVID-19 vaccine in children between six months and 5 years.
Ampio shares continue to fall following the company’s announcement that the FDA rejected proposed changes to a Phase III study of its treatment for osteoarthritis of the knee and other joints.
The FDA noted that the EUA application for Novavax’s COVID-19 shot may take a while to be resolved, citing an “incredibly complex review process.”
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
The company brings to the arena bioengineered tissues that repair, restore or replace an organ or tissue functioning, called Tissue Therapeutics.
The FDA has issued a Complete Response Letter (CRL) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) to Teva Pharmaceuticals and MedinCell.
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