Eagle Pharmaceuticals have been granted their U.S. Patent No. 11,103,483 titled, “Formulations of Bendamustine”, by the U.S. Patent and Trademark Office (USPTO). Eagle plans to submit this patent to be included in the FDA’s (Food and Drug Administration’s) Orange Book...
The US FDA (Food and Drug Administration) has expanded their approval of brivaracetam (Briviact, UCB) to now be used as both a monotherapy or adjunctive therapy for pediatric patients, as young as 1 month old, who suffer with partial-onset seizures, meaning that all...
BioCryst Pharmaceuticals have announced that Health Canada accepted their new drug submission for ORLADEYO® (berotralstat) for review for the prevention of recurring attacks in patients aged 12 years and older who have hereditary angioedema (HAE). Similarly,...
A spokesperson from the U.S. Food and Drug Administration (FDA) reported that the FDA has no intentions of resuming onsite GMP foreign inspections for non-“mission critical” operations during the COVID-19 pandemic. Further, the agency intends on continuing...
In their updated safety communication, the US FDA (Food and Drug Administration) states that the safety and efficacy of robotically assisted surgical (RAS) devices is still to be determined in the prevention and treatment of breast cancer. While the use of RAS devices...
Marketed under the name, Comirnaty, The US FDA (Food and Drug Administration) granted the Pfizer-BioNTech COVID-19 vaccine full approval yesterday, the first COVID-19 vaccine to become fully licensed in the US. In the US, the vaccine is now approved for people aged 16...
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