The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Initial results from a vaccine trial reported Sept. 20 showed that Pfizer and BioNTech’s Covid-19 vaccine might be safe for use in children under 12 years old.
Moderna Inc. is planning to double the size of an ongoing trial testing the company’s Covid-19 vaccines in children aged 6 months to less than 12 years.
Moderna Inc. is in talks with U.S. regulators to expand the size of an ongoing trial testing the company’s Covid-19 vaccines in children aged between 5 and 11 years, the drugmaker said on July 26.
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.
