FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines
The vaccine maker said the regulator placed the hold because of a report of a “serious adverse event” of motor neuropathy in ...
Novavax’s stock slides 19% after FDA puts clinical hold on COVID and flu vaccine candidates
Novavax Inc.’s stock tumbled 16% early Wednesday after the company said the FDA has placed a clinical hold on its ...
FierceBiotech2d
FDA puts Novavax's phase 3 plan for pair of vaccine programs on hold over nerve disease case
Novavax’s plans for growth outside of its COVID program have been thrown into chaos after the FDA put the biooharma's flu ...
BioSpace2d
Novavax Shares Slide as FDA Pauses COVID/Flu Vaccine Candidates
The clinical hold affects Novavax’s COVID-flu combo and standalone flu vaccines, which were on the cusp of Phase III testing.
pharmaphorum2d
FDA clears third emergency COVID-19 vaccine from J&J
The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Janssen’s ...
FDA puts Novavax flu vaccine trials on hold
The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 ...
FDA Puts Speed Breaker On Novavax's COVID/Flu Combo Shot Trial On Concerns Related To Damaged Nerves
The clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S. who received the vaccine in January ...
FDA Puts Clinical Hold On Novavax COVID-19-Influenza Combo Vaccine Candidate; Stock Tumbles
Wednesday said the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its COVID-19-Influenza ...
Novavax reports FDA placed clinical hold on IND for COVID-flu combo vaccine
Novavax announced that the U.S. Food and Drug Administration has placed a clinical hold on Novavax’s Investigational New Drug ...
USA Today3y
Questions about the COVID-19 vaccine answered by the FDA commissioner
A: Yes, for an anthrax vaccine (in 2005 ... Q: How many people does the FDA have working on COVID-19 vaccines? A: We have a review group that is set up and meets regularly.
Novavax Stock Plunges After FDA Pauses Covid, Flu Vaccine Trials
Novavax shares tumbled after the Food and Drug Administration put a clinical hold on its testing applications for a combined ...