AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for the company’s treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).
Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug somatrogon after the U.S. Food and Drug Administration accepted the companies’ Biologics License Application (BLA) for the therapy.
Ridgeback Biotherapeutics LP’s Ebanga is the first FDA-approved, single-injection Ebola treatment which is available in a lyophilized form.
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.