Policy · 117th Congress
House report questions FDA’s approval of Alzheimer’s drug
A decision on accelerated approval is due by Jan. 6, and the company is simultaneously submitting data for full approval based on results from a Phase 3 trial.
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A decision on accelerated approval is due by Jan. 6, and the company is simultaneously submitting data for full approval based on results from a Phase 3 trial.
Opponents spent nearly $23 million against the initiative; advocates spent more than $6 million.
The Biden administration’s Oct. 6 announcement that it would revisit that classification comes after previous, yearslong reviews of marijuana’s categorization fell flat, and experts are split on
It also may not be clear what the outcome of Senate control will be until after Dec. 6 if the Georgia race goes to a runoff, which could leave little time for a burst of legislative action before lawmakers
The Pfizer shot, for children 6 months to 4 years old, is a three-dose vaccine with three micrograms per dose.
Moderna said Thursday that it asked the Food and Drug Administration for emergency use authorization of its COVID-19 vaccine in kids under age 6, making it the first drug company to do so.
Upton was among the Republican House members who voted in favor of impeaching President Donald Trump after the Jan. 6, 2021, insurrection at the Capitol.
Patient groups, many of which have close ties to drugmakers developing treatments, say the move will block most of the country’s 6 million Alzheimer’s patients from a potential opportunity to slow
The FDA had planned to meet on Feb. 15 to review a two-dose regimen of the Pfizer shots for young children ages 6 months to 4 years old, but officials on Friday said the agency needs more time to
The FDA has been independently verifying the data supporting the safety and efficacy of the kid-sized doses, in addition to data showing they are necessary, since Oct. 6.
Members voted, 9-6, for those who are 18 to 49 with underlying conditions.
Alzheimer’s afflicts more than 6 million Americans, and is the sixth-leading cause of death in the United States.
The other 6 million doses will go to countries that are regional priorities or partners.
Many states reported that the Johnson & Johnson vaccine comprised just 4 to 6 percent of total vaccines supplied to the state so far, and were expecting only a trickle of doses over the next month