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.
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.
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.
Johnson & Johnson submitted data to the U.S. Food and Drug Administration for emergency use authorization of a booster shot of the company’s Covid-19 vaccine in people aged 18 and older.
Inovio Pharmaceuticals Inc. said the company’s Covid-19 vaccine candidate was safe, well-tolerated and produced immune response against the new coronavirus in a mid-stage clinical trial, sending the drug developer’s shares up over 3 percent.
Just more than half of U.S. adults have received at least one Covid-19 vaccine dose, data from the U.S. Centers for Disease Control and Prevention showed on April 18, with nearly 130 million people aged 18 years or more having received their first shot.
The U.S. government on Feb. 27 authorized Johnson & Johnson’s single-dose Covid-19 vaccine, enabling millions more Americans to be vaccinated in the coming weeks and setting the vaccine up for additional approvals around the world.
The European Commission approved Aimmune Therapeutics Inc.’s Palforzia for the treatment of peanut allergy.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices voted to recommend the use of Moderna Inc.’s Covid-19 vaccine on people 18 years of age and older.