Novavax Gets FDA Approval To Resume Testing 2 Vaccines

Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
The company said further information supported its contention that the vaccine did not cause ... COVID-19-flu and standalone flu vaccines. The company explained that the U.S. Food and Drug Administration (FDA) removed its clinical hold on the studies ...
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.
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,
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 stock soars as FDA removes clinical hold on its COVID and influenza shot
Investing.com -- 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 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 climbs as FDA lifts clinical hold on Covid, flu combo trials
Novavax (NVAX) shares surge 12% as FDA lifts clinical hold on COVID-19-Influenza Combination vaccine candidates.
STAT6d
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 Democrat3h
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.
“Pack your bags” RFK Jr. tells FDA. His war on public health under Trump would only accelerate
In an interview with NPR on Wednesday, Kennedy said Trump had already assigned him three tasks: to reduce the “corruption and ...
Moderna reports surprise profit on higher-than-expected COVID vaccine sales
Moderna reported a surprise third-quarter profit on Thursday, driven by cost cutting and higher-than-expected sales of its ...
BioSpace4d
Moderna Gets Better-Than-Expected Q3 COVID-19 Vaccine Sales, but RSV Shot Disappoints
While Moderna’s Spikevax beat Wall Street estimates in the third quarter, William Blair analyst Myles Minter in a Thursday ...