FDA, Novavax and Covid 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.
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.
FDA slaps clinical hold on Novavax' COVID-19 flu combo trial IND
Shares of US protein-based vaccine maker Novavax closed down 19.4% at $10.15 yesterday having dropped as much as 24%, on the news of a setback for its investigational application for a covid vaccine.
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,
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.
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.
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
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 trial of a combination shot for COVID-19 and influenza.
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.
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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 ...
biopharma-reporter3d
FDA places hold on Novavax’s COVID-influenza combo vaccine
A report of a case of motor neuropathy in a patient who received the vaccine last year has led the FDA to halt its ...
ABC712d
FDA approves 1st at-home nasal spray flu vaccine, paving the way for other medicines
The FDA has approved a new flu vaccine nasal spray for at-home use. While this self-administered version won't be available ...