Children have milder COVID-19 symptoms than adults and the balance of evidence suggests they may also have lower susceptibility and infectivity than adults, scientists advising the British government said.
Oxford University and AstraZeneca are recruiting around 10,000 adults and children in Britain for trials of an experimental coronavirus vaccine, a day after receiving U.S. backing worth up to $1.2 billion.
The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) for the treatment of heart failure in adults with reduced ejection fraction.
Merck’s vaunted checkpoint inhibitor Keytruda picked up another regulatory approval. The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
The U.S. Food and Drug Administration approved Seattle Genetics’ Tukysa (tucatinib) in combination with chemotherapy agents trastuzumab and capecitabine for adults with HER2+ breast cancer that cannot be surgically removed or has metastasized to other parts of the body.
The U.S. Food and Drug Administration granted expedited approval to UroGen Pharma’s Jelmyto (mitomycin) for pyelocaliceal solution for adults with low-grade upper tract urothelial cancer (LG UTUC) on the basis of data from the Phase III OLYMPUS trial.
Neurelis Inc. announced the commercial availability of Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
Seqirus snagged U.S. FDA approval for Fluad Quadrivalent, the first quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.
Incyte’s ruxolitinib cream hit the drug’s primary endpoint in the Phase III TRuE-AD2 trial of atopic dermatitis in adolescents and adults. Incyte and Eli Lilly announced topline results from the Phase III trial (FREEZE-AD4) of baricitinib in topical corticosteroids for the treatment of adults with moderate to severe atopic dermatitis who did not respond to treatment with cyclosporine.
The U.S. Food and Drug Administration approved an expanded indication for Sanofi’s Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages 6 years and older. The expanded indication approved by the FDA applies to both type 1 and 2 diabetes. Previously, Toujeo was U.S.-approved only for adults aged 18 years and older.