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...
FDA approves new drug Leqembi to treat early Alzheimer’s disease
By
Alicia Lasek
Jan 09, 2023
The newly approved drug Leqembi (lecanemab) may slow progression of cognitive decline due to Alzheimer’s disease, trial data show. CMS says it may rethink Medicare coverage of drugs in Leqembi’s...
Vaccine to protect seniors from RSV ready for FDA review, drugmaker says
By
Alicia Lasek (f3)
Jun 13, 2022
A vaccine to help prevent a leading cause of pneumonia in the elderly has been found effective in late-stage clinical trials.
FDA halts use of REGEN-COV, Eli Lilly monoclonal antibodies
By
Alicia Lasek
Jan 26, 2022
The Food and Drug Administration has revoked its emergency use authorizations for two monoclonal antibody cocktails that have served as COVID-19 treatment mainstays in long-term care facilities.
FDA set to approve two COVID-19 antiviral pills this week
By
Alicia Lasek
Dec 22, 2021
FDA is expected to grant emergency use authorization to two antiviral COVID-19 pills this week, possibly as early as today, according to Bloomberg News, citing sources familiar with the matter.
FDA OKs first injectable antibody drug to prevent COVID-19 in high-risk patients
By
Alicia Lasek
Dec 10, 2021
One dose of injectable Evusheld may be effective for 6 months, FDA says. The drug neutralizes all previous SARS-CoV-2 variants, and AstraZeneca says it is working to establish its efficacy against the...
FDA panel recommends second J&J coronavirus vaccine dose for adult recipients
By
Alicia Lasek
Oct 18, 2021
Independent experts have unanimously agreed that a full second dose of the drugmaker’s COVID-19 vaccine be offered to adults aged 18 years and older at least two months after receipt of the first...
FDA may authorize half-dose booster of Moderna’s coronavirus vaccine
By
Alicia Lasek
Sep 30, 2021
A 50-microgram dose appears to be effective enough to increase waning vaccine protection, and may reduce the risk of side effects, sources tell investigators.
Drugmakers ask FDA to approve another Alzheimer’s drug, similar to Aduhelm
By
Alicia Lasek
Sep 29, 2021
Drugmakers Eisai and Biogen are putting the Food and Drug Administration to the test with a request to approve a second Alzheimer’s drug that works like aducanumab (Aduhelm), the new, yet controversial,...
FDA, WHO officials warn against rush to COVID boosters
By
Alicia Lasek
Sep 14, 2021
A booster vaccination campaign that is rolled out without solid scientific justification could lower public confidence in vaccines and undermine messaging about the value of primary vaccination, say two...