With strong data from Moderna and Pfizer, the projection for an EUA by the end of 2020 still may hold despite holidays and other obstacles to completing the necessary work.
A 2020 emergency use authorization for a coronavirus vaccine still remains possible with interim data now available, but with less than two months left in the year, the pressure on US Food and Drug Administration staff to meet the expectation is growing.
Moderna, Inc. became the second vaccine sponsor to report interim results with its 16 November announcement that the independent...
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
