FDA, Novavax

Novavax stock soars as FDA removes clinical hold on its COVID and influenza shot
The U.S. Food and Drug Administration (FDA) has lifted its hold on a late-stage trial for Novavax’s COVID-influenza combination and standalone flu vaccines, the company reported on Monday (NASDAQ:MNDY).
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 lifts clinical hold on Novavax' combo COVID-19 flu jab study
The US Food and Drug Administration (FDA) has removed the clinical hold on the 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
Jacobs acknowledged that Novavax does not have the market leverage and scale of French drugmaker Sanofi, with which it signed a licensing deal earlier this year to sell its COVID vaccine from 2025 in several markets, including the U.S. and Europe.
FDA lifts clinical hold on combined COVID-19-influenza vaccine trials
Novavax received clearance from the FDA to move forward with phase 3 clinical trials for its COVID-19-influenza combination (CIC) and standalone influenza vaccines. The FDA lifted a clinical hold that had been placed on Novavax's investigational new drug ...
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 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.
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.
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Biotech Stock Roundup: NVAX Q3 Results, SNDX Down on AML Data, RNA Surges on Study Data
As the third-quarter earnings season ends this week, the focus in the biotech sector is mostly on pipeline and key regulatory ...
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Novavax’s Market Share and Pipeline Uncertainties Lead to Sell Rating
J.P. Morgan analyst Eric Joseph maintained a Sell rating on Novavax (NVAX – Research Report) yesterday and set a price target of $9.00. Eric Joseph has given his Sell rating due to a combination of ...
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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 ...
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Novavax Third Quarter 2024 Earnings: Beats Expectations
Revenue: US$84.5m (down 55% from 3Q 2023). Net loss: US$121.3m (loss narrowed by 7.2% from 3Q 2023). US$0.76 loss per share ...