EU Vaccinated 70% of Adult Population Against COVID-19
The European Commission announced that 70% of adults in the European Union (EU) are fully vaccinated against COVID-19, meeting the target that was initially set in January 2021, at the start of the vaccine rollout. This milestone marks a success for the EU's...
Eagle Receives USPTO Additional Patent for Bendamustine
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...
Seizures in Children: FDA Expands Approval for UCB Briviact
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 ORLADEYO Reviewed by Health Canada and Swissmedic
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,...
FDA Will Not Resume Onsite GMP Foreign Inspections Amidst COVID-19
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 to use...
FDA Updates RAS Devices Safety Communication for Mastectomies
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...
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