Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and ...
At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.
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US FDA Commissioner Makary says FDA supports mRNA vaccines but US taxpayers should not bear the cost
U.S. Food and Drug Administration Commissioner Marty Makary on Monday defended his agency's position and record on mRNA vaccines, days after it changed course and agreed to review a Moderna flu ...
A new investigation has found irregularities in the ethics review of a grant to study effects of a birth dose of hepatitis B vaccine in Guinea-Bissau.
Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.
German biopharmaceutical company BioNTech sued Moderna in Delaware federal court on Thursday, alleging that Moderna's COVID-19 shot mNEXSPIKE infringes a patent related to COVID vaccine technology.
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