Novavax to Move Forward With Covid-19-Flu Vaccine

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 lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
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
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 climbs as FDA lifts clinical hold on Covid, flu combo trials
Novavax (NASDAQ:NVAX) shares climbed 12% premarket on Monday after the U.S. FDA lifted clinical hold on the investigational new drug application for the pharma firm’s COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.
FDA Lifts Clinical Hold On Novavax COVID-19-Influenza Combo Vaccine Candidate; Stock Up
Monday said the Food and Drug Administration or FDA has removed the clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. Novavax shares were up more than 13 percent in pre-market.
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).
Business Wire1h
Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial
today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug (IND) application, ARCT-2304, a ...
STAT7d
A Q&A with the FDA’s top vaccine regulator amid a fresh wave of disinformation
A fresh wave of disinformation about vaccines is flaring amid the 2024 campaign. The FDA's top vaccine official believes ...
JD Supra3d
FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings
On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, ...
The Union Democrat10h
Mayo Clinic Minute: 3 misconceptions about COVID-19 and flu vaccines
"You aren't going to get the flu from the flu vaccine. You're not going to get COVID from the ... are licensed or ...
Expert explains three misconceptions about COVID-19 and flu vaccines
Dr. Robert Jacobson, medical director for Mayo Clinic's Primary Care Immunization Program, clears up some misconceptions about COVID-19 and the flu.
Glamour on MSN10h
The RSV Vaccine for Infants: Everything Parents Need to Know
The other group at the highest risk when it comes to RSV is children under age five, and specifically infants—especially ...
devdiscourse2d
Global Health Updates: Pharma Tariffs, RSV Vaccine Approval, and Infant Formula Insights
Recent health news highlights include Recordati's nonchalance towards potential U.S. tariffs, Canada's approval of Moderna's ...