Decision to allow boosters for 12- to 15-year-old recipients of the Pfizer/BioNTech vaccine will go before CDC's ACIP, but like several other recent changes for COVID vaccines, the US FDA opted to skip its advisory committee.
In what is becoming a familiar routine, the US Food and Drug Administration expanded the emergency use authorization for the Pfizer Inc./BioNTech SE coronavirus vaccine to allow more groups to receive an additional dose, as well as shortened the time between the primary series and third shot, without an advisory committee meeting.
Children age 12 to 15 now are eligible for a booster shot of the Pfizer/BioNTech vaccine, the FDA announced on...
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
