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...
Pfizer COVID-19 Vaccine Received Full FDA Approval
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...
COVID-19 Shots in Pregnant Women Lead to Antibody Transfer
A study has found that pregnant women who receive their first messenger RNA–based COVID-19 vaccine during their pregnancy, produce antibodies for COVID-19 as early as five days following inoculation. The study also found that within 16 days following the first...