The U.S. Food and Drug Administration expanded the indication of Supernus Pharmaceuticals Inc.’s Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older.
UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.
The U.S. Food and Drug Administration approved the expanded use of Bristol Myers Squibb’s cancer drug Opdivo along with chemotherapy as treatment that patients with an aggressive form of lung cancer receive before surgery.
The U.S. health regulator approved Eli Lilly and partner Boehringer Ingelheim’s drug, Jardiance, for expanded use in reducing the risk of death and hospitalization for all patients with heart failure.
ViiV Healthcare’s HIV treatment Cabenuva was approved by the U.S. Food and Drug Administration for use every two months, meaning patients only have to receive an injectable dose six times per year.
At least 1 in 5 Americans have been infected with COVID-19. In other news, the U.S. Food and Drug Administration approved Gilead Sciences’ supplemental New Drug Application for Veklury (remdesivir) for adults and adolescents with COVID-19 who are not hospitalized but are at high risk of progression to severe COVID-19, hospitalization or death.
The U.S. Food and Drug Administration approved Seqirus’ Flucelvax Quadrivalent (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine, for an expanded age indication for children as young as 6 months old.
The U.S. Food and Drug Administration approved Vertex Pharmaceuticals Inc.’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for use in people with cystic fibrosis with certain rare mutations.
Britain’s healthcare watchdog NICE recommended Roche’s medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the medicine in 2017.
GSK announced it received approval from the U.S. FDA’s Center for Biologics Evaluation and Research expanding the indication for FLUARIX QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older.