FDA, Novavax

FDA lifts clinical hold on Novavax's combo COVID-flu shot
The 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 identifying a safety concern.
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.
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 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.
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 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 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 and standalone flu vaccine that had been put on hold.
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.
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Novavax Stock is Slipping After the Vaccine Maker Cut its Outlook Again
The COVID-19 and flu vaccine maker said it expected full-year revenue of ... Shares of Novavax fell about 5% Tuesday ...
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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 ...