Novavax, FDA

US FDA lifts clinical hold on Novavax's combo COVID-flu shot
The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after a safety concern was found to be unrelated to the combination shot,
FDA removes clinical hold on Novavax’s COVID-19-influenza combo vaccine
The FDA had put a clinical hold on Novavax’s COVID-19-influenza combo vaccine after an adverse event in a patient.
FDA Gives Green Signal To Novavax's COVID-19-Influenza Combo Vaccine Late-Stage Trial
On Monday, the FDA removed the clinical hold on Novavax Inc.’s (NASDAQ:NVAX) Investigational New Drug (IND) application for its COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.
Novavax cuts 2024 revenue forecast again on lower COVID vaccine sales
Novavax's COVID vaccine brought in sales of $38.21 million for the third ... which Novavax said this week got the green light from the U.S. FDA to resume clinical testing. Novavax does not expect a significant impact from the clinical hold and plans ...
Novavax to Move Forward With Covid-19-Flu Vaccine After FDA Lifts Clinical Hold -- Update
Novavax is already poised to benefit from a separate combined Covid-flu vaccine via a deal with Sanofi announed earlier this year. Under the $1.4 billion co-licensing agreement, announced in May, Sanofi will have the sole right to use Novavax's existing Covid-19 vaccine in combination with its own flu vaccine.
Novavax: FDA removes clinical hold on Covid-19/flu combo trial
Novavax (NVAX) announced that the U.S. FDA has removed the clinical hold on Novavax’s Investigational New Drug application for its
FDA Lifts Hold on COVID-Flu Combo Vaccine Trial
The FDA has lifted its clinical hold on Novavax's combined COVID-19 and influenza vaccine trial, finding no link between the vaccine and a reported adverse neurological event. This decision enables Novavax to resume late-stage testing.
FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine
The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.
Novavax sees weak Covid vaccine sales, convinced Sanofi can do better
Novavax has made a smaller splash in the U.S. Covid-19 vaccine market than it had hoped. But it's betting on licensing deals and a pipeline of new vaccines it's now evaluating for R&D.
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Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu ... not related ...
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FDA lifts pause on Novavax flu vaccine trials
The Food and Drug Administration has cleared Novavax to move forward with testing of a combination vaccine for COVID-19 ...
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Novavax Resumes Phase 3 Vaccine Trials After FDA Hold
The latest update is out from Novavax ( (NVAX)). Novavax, a leader in vaccine development, announced the FDA’s removal of a clinical hold on their COVID-19-Influenza combination and ...
Novavax Stock is Slipping After the Vaccine Maker Cut its Outlook Again
Novavax shares dropped Tuesday morning after the company slashed its full-year outlook when it announced its third-quarter ...