Pfizer asks FDA to approve omicron-specific booster shot
Aug 22, 2022
The drug company says that its new mRNA vaccine produces an immune response against the BA.4 and BA.5 omicron subvariants.
Pfizer, BioNTech to pursue 2nd booster shot authorization for older adults
By
Alicia Lasek
Mar 16, 2022
A second booster — or fourth dose — will be necessary to improve the vaccine’s waning protection in the face of omicron, Pfizer’s CEO has stated. Whether the FDA will find the evidence compelling...
FDA advisers support full approval of Paxlovid for at-risk older adults
By
Alicia Lasek
Mar 16, 2023
The antiviral drug Paxlovid should receive full FDA approval to treat COVID-19 in older adults at risk of severe outcomes, the advisers decided in a Thursday vote.
VHA to cover new Alzheimer’s drug Leqembi, despite CMS’s restraint
By
Alicia Lasek
Mar 14, 2023
The Veterans Health Administration will provide coverage for the recently approved drug lecanemab (Leqembi) to qualified veterans with early Alzheimer’s disease. It’s a surprise move considering...
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...
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.
