FDA expands use of remdesivir to skilled nursing, other non-hospital settings
By
Alicia Lasek
Jan 25, 2022
Remdesivir, the first FDA-approved COVID-19 drug, now can be used in adult and pediatric patients with mild-to moderate COVID-19 illness at high risk of progressing to severe disease, the agency has announced.
FDA authorizes monoclonal antibody that tackles omicron
By
Alicia Lasek
Feb 15, 2022
Bebtelovimab is greenlit for treatment of mild to moderate COVID-19 in patients at high risk of severe disease. The move comes amid a federal push to increase supply of effective therapies.
FDA greenlights Novavax’s COVID-19 vaccine, adding unique option to U.S. arsenal
By
Alicia Lasek (f3)
Jul 14, 2022
The FDA late Wednesday authorized Novavax’s adjuvanted COVID-19 vaccine for emergency use in adults aged 18 years and older.
Feds mull swift sanction of 2nd coronavirus booster
By
Alicia Lasek
Mar 25, 2022
The Biden administration may authorize a second booster shot within weeks, a new report finds. Officials want to get ahead of an expected uptick in SARS-CoV-2 infections, sources say.
New FDA initiative seeks to boost clinicians’ dietary supplements knowledge
By
Alicia Lasek (f3)
Jun 03, 2022
Educational supports for healthcare providers include a continuing education program on the benefits and risks of dietary supplements.
Lawmakers push to keep ‘ineffective’ new opioids from market
By
Alicia Lasek
Mar 08, 2023
Congressional lawmakers have renewed efforts to give the Food and Drug Administration more power to deny drug applications for opioids that are not proven clinically superior to and lower risk than currently...
Feds gauging threat to vaccine, test and treatment efficacy in face of omicron variant
By
Alicia Lasek
Dec 01, 2021
The United States is prepared to address any potential threat to the effectiveness of COVID-19 vaccines, tests and treatments posed by the new variant, according to the White House and federal health officials.
FDA advisers vote unanimously to endorse Novavax’s COVID-19 vaccine
By
Alicia Lasek (f3)
Jun 08, 2022
Independent advisers have voted 21 to 0 to recommend the authorization of Novavax’s COVID-19 protein-based vaccine for pandemic emergency use.
Boosters on the way: LTC residents, healthcare workers may top fed’s list after CDC approves 3rd shot
By
Alicia Lasek
Aug 16, 2021
The Biden administration has secured 100 million COVID-19 vaccine doses as part of a strategy to provide additional shots to already vaccinated priority groups this fall, investigators have been told....
Merck to seek emergency use for COVID-19 antiviral pill that cuts severe outcomes by 50 percent
By
Alicia Lasek
Oct 04, 2021
Molnupiravir has reduced COVID-19 deaths and hospitalizations by half in a new clinical trial. An orally delivered drug could offer unprecedented treatment convenience, the drug’s developers say.