FDA OKs third antibody COVID therapy; variants spur new pause on another
By
Alicia Lasek
Jun 01, 2021
A new COVID-19 treatment made by GlaxoSmithKline now is the third monoclonal antibody therapy federally authorized to help prevent severe disease outcomes in high-risk patients. But gene variants are interfering...
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.
FDA calls for investigation into its approval of controversial Alzheimer’s drug
By
Alicia Lasek
Jul 12, 2021
The acting chief of the Food and Drug Administration has called for an investigation into the events leading up to the approval of Biogen’s brain plaque-clearing dementia drug aducanumab (Aduhelm).
CDC chief endorses COVID booster shots for nursing home residents, healthcare workers
By
Alicia Lasek
Sep 24, 2021
Older and medically compromised adults and workers in high-risk settings should be offered third doses of the Pfizer-BioNTech vaccine, CDC Director Rochelle Walensky, M.D., said early Friday. Her decision...
CDC briefing: Top officials talk up vaccine plans, focus on long-term care
By
Alicia Lasek
Oct 22, 2020
Federal health officials touted transparency and nationwide distribution plans while keeping their eye on Phase 1 vaccine recipients, including LTC residents and workers.
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.