The Janssen COVID-19 vaccine is now limited to certain individuals ages 18 and up after the U.S. Food and Drug Administration downgraded its emergency use authorization.
The U.S. Food and Drug Administration expanded the indication of Supernus Pharmaceuticals Inc.’s Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older.
Moderna Inc. on late March 17 sought emergency use authorization from U.S. health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic.
Pfizer Inc. and the company’s German partner BioNTech SE on March 15 filed an application with U.S. regulators seeking emergency use authorization for a second booster shot of their COVID-19 vaccine for people aged 65 and older.
The director of the U.S. Centers for Disease Control and Prevention (CDC) signed off on the U.S. Food and Drug Administration’s full approval of Moderna Inc.’s COVID-19 vaccine in those aged 18 and over, the agency said on Feb. 4.
Novavax Inc. filed for emergency use authorization of the company’s COVID-19 vaccine for U.S. adults, a long-awaited step following months of struggles with development and manufacturing problems.
The U.S. Food and Drug Administration on Jan. 31 gave full approval to Moderna Inc.’s COVID-19 vaccine for people ages 18 and older, making Spikevax the second fully approved vaccine for the virus.
Moderna Inc. started a mid-stage study, testing a booster dose of the company’s COVID-19 vaccine specifically designed to target the Omicron coronavirus variant, a day after rival Pfizer Inc. launched a similar trial.
The U.S. Food and Drug Administration approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts 30 percent of patients with psoriasis.
The U.S. Food and Drug Administration approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients positive for anti-acetylcholine receptor (AChR) antibody.