Vaccines and Related Biological Products Advisory Committee members agree another option should be made available, especially if Novavax's protein-based design could encourage those who refused the mRNA vaccines to be inoculated.
Novavax, Inc.’s proposed COVID-19 vaccine easily cruised to a favorable recommendation for emergency use authorization from the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, but a warning about a risk of myocarditis also seems inevitable.
The committee voted 21-0 with one abstention on 7 June that the benefits of the vaccine outweigh the risks and...
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
