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Novavax said it will submit the findings to global regulators during the first quarter of this year to support authorizations for adolescents. Read More
Lilly claimed bebtelovimab was shown to maintain neutralizing activity against the predominant Omicron variant and its more transmissible BA.2 subvariant. Read More
Pfizer and BioNTech announced Friday that they will hold off pursuing an expanded FDA Emergency Use Authorization (EUA) permitting use of their COVID-19 vaccine in children under age five, in order to gather more data on whether a third booster dose is needed. Read More
The Senate is scheduled to hold a cloture vote on the nomination of Robert Califf for the position of FDA commissioner today at 5:30 pm, which indicates that Senate Majority Leader Chuck Schumer (D-N.Y.) believes he has the votes needed to get Califf confirmed in a floor vote of the evenly divided Senate. Read More
The European Medicines Agency’s (EMA) safety committee has recommended that the EU suspend authorizations for hydroxyethyl-starch (HES) solutions for infusion after concluding that the products are being administered in a potentially harmful manner. Read More
An RNA treatment targeting a rare genetic eye disease has posted disheartening phase 2/3 results, failing to significantly improve vision in those who received the drug. Read More
Amid accusations of manipulating data associated with trials for its Alzheimer’s drug candidate simufilam, Cassava Sciences had a bit of good news when the FDA denied a citizen petition pressing the agency to investigate claims that Cassava changed trial data. Read More
Sen. Wyden had expressed his concerns over the potential misuse of the accelerated approval pathway and asked Califf to answer how he would reform the program if confirmed as FDA commissioner. Read More