Food and Drug Administration (FDA)
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Pfizer reported three cases of muscle weakness, two of which involved inflammation of the heart (myocarditis).
The Phase II trial, VLA150202, evaluated the safety and immunogenicity of VLA15 on 246 healthy adults aged 18 to 65 years old across the United States.
Biogen agreed to pay $22 million in response to allegations that it violated the False Claims Act, and now, life insurance company Humana is suing Biogen over a similar scheme.
Peter Marks will serve as acting director of the Office of Vaccines Research and Review at the U.S. FDA following the resignation of two top officials at the agency.
Intra-Cellular Therapies published its Study 404 Phase III trial of lumateperone as monotherapy for major depressive episodes associated with bipolar I or bipolar II disorder.
Biohaven Pharma’s latest update on its Phase III clinical trial to use verdiperstat as a potential treatment for multiple system atrophy showed that it did not meet its expected outcomes.
The U.S. Food and Drug Administration is wrapping up the end of September and beginning October with two PDUFA dates. Here’s a look.
The approval is based on its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy for treating chronic GVHD after allogeneic stem cell transplantation.
The Neurology Center posted a notice, saying, “At this time, the NCPA physicians will not be recommending this treatment for any of its patients.”
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