U.S. health regulators approved Roche’s arthritis drug Actemra for emergency use to treat hospitalized Covid-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
The U.S. Food and Drug Administration granted marketing clearance for Ryplazim as the first FDA-approved therapy for the treatment of patients with the plasminogen deficiency type 1 (hypoplasminogenia), a rare genetic disorder.
The U.S. Food and Drug Administration approved Novartis’ blockbuster drug Cosentyx (secukinumab) for pediatric patients aged 6 years and older with moderate-to-severe plaque psoriasis. The new approval for Cosentyx marks the first for a pediatric patient population in the United States.
Fennec Pharmaceuticals resubmitted the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration for the pediatric chemotherapy-induced hearing loss prevention drug Pedmark.
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.