At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 ...

Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...

That may have been the situation for Novavax’s COVID-19 vaccine, which was expected to win a full approval from the FDA by April 1 ... are more vulnerable to review delays given the heightened ...

Novavax (NasdaqGS ... for deciding on the traditional approval of the vaccine. When asked if the delay resulted from "personnel being shuffled" at the FDA, Kennedy attributed it to the vaccine's ...

When asked if the delay resulted from "personnel being shuffled ... in the stock market remains a primary goal for […] The FDA was supposed to make a final decision about approval of Novavax's ...

Biotechs have faced delays in scheduling meetings and receiving feedback from the FDA that guides drug ... on a COVID vaccine from Novavax, but gave a green light to a pre-filled syringe version of ...

After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial ... and following all the steps for approval, only to “prepare a $100 million ...

“With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly ...

Dupilumab is now approved for CSU patients aged 12+ not controlled by H1 antihistamines, targeting IL-4 and IL-13 pathways. Phase 3 trials showed significant reductions in itch and urticaria ...

The FDA granted the “breakthrough device” designation to the research group’s Damo Panda model, allowing for an expedited review and approval process, Alibaba said in a statement on Thursday.