FDA, Novavax and flu vaccine
Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge
The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial.
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 COVID-19-and-flu combination and stand-alone flu vaccine candidates, following a case of motor neuropathy in a participant in a mid-stage trial.
FDA Freezes COVID-Flu Combo Vaccine Trial Over Safety Concern
The U.S. Food and Drug Administration has put a trial of Novavax’s COVID-influenza and its standalone flu vaccines on hold after a participant who took the combination shot reported nerve damage, the company said.
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. The FDA’s decision stems from a report of a serious adverse event of motor neuropathy,
Novavax Stock Plunges as FDA Puts Hold on Vaccines Because of Safety Concerns
The Food and Drug Administration put clinical holds on Novavax's COVID-19 and flu combination vaccine and its standalone flu shot because of safety concerns.
FDA pauses Novavax's flu-COVID vaccine trial, stock sinks 20%
The Food and Drug Administration (FDA) is placing a hold on Novavax's (NVAX) experimental flu-COVID vaccines after a patient reported developing motor neuropathy tied to a vaccine from a phase two trial in 2023.
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 Covid-flu vaccine and standalone flu inoculation due to safety concerns. Fi
Novavax Stock Plummets as FDA Pauses Clinical Trial on Safety Concerns
Novavax stock fell sharply Wednesday after the U.S. Food and Drug Administration halted one of the vaccine maker’s clinical trials, citing safety concerns.Shares plummeted 18% to $10.32 in midday trading.
FDA Puts Speed Breaker On Novavax's COVID/Flu Combo Shot Trial On Concerns Related To Damaged Nerves
Novavax Inc. (NASDAQ:NVAX) stock is trading lower on Wednesday. The FDA has placed a clinical hold on Novavax’s Investigational New Drug (IND) application for its COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.
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 ...
FierceBiotech4d
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 ...
Is one COVID vaccine better than the others? An infectious disease doctor breaks it down
Which COVID vaccine is better of the Pfizer, Modern and Novavax options? Here's how they compare with safety and efficacy and ...
pharmaphorum4d
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.
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.