Enzyvant Sciences resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the company’s tissue-based regenerative pediatric congenital athymia therapy RVT-802.
Shares of Supernus Pharmaceuticals climbed in trading on April 5 after the U.S. Food and Drug Administration’s April 2 approval of the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.
Shares of Ovid Therapeutics soared in trading after the company announced pharma giant Takeda signed a licensing agreement valued at $856 million to secure global rights to the investigational medicine soticlestat for the treatment of two forms of rare epilepsy.
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.