Food and Drug Administration (FDA)
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Research into Alzheimer’s disease is shifting from amyloid plaque and tau protein to neuroinflammation, white matter changes and insulin resistance.
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
Sangamo Therapeutics announced positive preliminary findings from its ongoing Phase I/II STAAR clinical trial in Fabry disease.
Amgen anticipates Lumakras (Amgen lung cancer drug) to become a cornerstone medicine as the company aims to develop multiple medications for the targets.
The annual Clinical Trials on Alzheimer’s Disease conference is scheduled for November 9-12, and Biogen plans to present data on its portfolio, including its controversial Aduhelm.
The decision follows a 14-0 vote among members of an expert panel advising the agency.
The drug makers have until February 28, 2022 to review their findings and analytical processes for the drug they are developing to treat relapsed and/or refractory multiple myeloma.
The FDA informed Moderna that it would need more time to evaluate the company’s Emergency Use Authorization (EUA) submission for its COVID-19 vaccine for adolescents 12 to 17 years of age.
GlaxoSmithKline denied reports that they were interested in acquiring Canada’s Aurinia Pharmaceuticals, although some reports claim they are preparing to bid.
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