The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
Gilead Sciences reported additional data from the company’s Phase III SIMPLE-Severe trial and a real-world retrospective group of patients with severe COVID-19.
Drugmaker Gilead Sciences will soon begin enrollment of pediatric patients with moderate-to-severe COVID-19 in a late-stage study testing the company’s experimental drug remdesivir.
Merck’s vaunted checkpoint inhibitor Keytruda won U.S. approval for a new indication.
The U.S. Food and Drug Administration approved a drug to treat infants and children with HIV, with the drug having been developed by drugmaker GlaxoSmithKline’s HIV drugs division ViiV Healthcare.
AstraZeneca and Merck & Co. announced that the U.S. Food and Drug Administration approved the kinase inhibitor Koselugo (selumetinib) for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.
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.
Teva Pharmaceutical’s deutetrabenazine for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome did not meet the primary endpoint in the Phase II/III ARTISTS 1 and Phase III ARTISTS 2 trials.
The U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy Palforzia as a first-of-its-kind treatment for the millions of people suffering from an allergy to peanuts.
The U.S. Food and Drug Administration approved Merck’s Dificid (fidaxomicin) for a new oral suspension as well as for the treatment of Clostridioides difficile-associated diarrhea (CDAD) in children ages 6 months and older.