The application to the EMA was based on results from a late-stage study that showed the drug slowed down the rate of cognitive decline in patients with early Alzheimer’s by 27%, compared with a placebo.
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The letter sent to the European Medicines Agency comes as antibiotics, including amoxicillin – used to treat bacterial infections and often prescribed for ear and chest infections in children – have been in short supply since October.
Reports of heavy periods – bleeding characterized by increased volume and/or duration that interferes with the quality of life – have been observed during clinical trials, from cases in the real world and in medical literature, according to the European Medicines Agency.
The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.
