On June 1, 2021, Aklermes announced FDA approval of LYBALVI™ for the treatment of schizophrenia and Bipolar I disorder. The following was published as part of their press release announcement: “Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly-efficacious atypical antipsychotic, is associated …
On June 7, 2021 the FDA approved a new treatment for Alzheimer’s – Aduhelm (aducanumab). The approval was granted through the “accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments”. The director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., …
On March 26, 2021, the U.S. Food and Drug Administration authorized the marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 years …
The initial issuance of this EUA for COVID-19 convalescent plasma was based on a review of historical evidence using convalescent plasma in prior outbreaks of respiratory viruses, certain preclinical evidence, results from small clinical trials of convalescent plasma conducted during the current outbreak, and data obtained from the National Convalescent Plasma Expanded Access Protocol (EAP) sponsored by the Mayo Clinic. …
