The Pfizer Inc./BioNTech SE Covid-19 vaccine was 93 percent effective in preventing hospitalizations among those aged 12 to 18, according to an analysis released by the U.S. Centers for Disease Control and Prevention (CDC) on Oct. 19.

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.