The Federal Trade Commission (FTC) is likely to soon begin an examination into pharmacy benefit managers (PBMs), which could impact drugmakers. Source: Drug Industry Daily

In a cloture vote late Monday, the Senate voted 49 to 45 to limit floor debate on the nomination of Robert Califf to the role of Commissioner of the FDA.…

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…

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…

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…

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. Source: Drug Industry Daily

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…

Global launches of novel active drug substances hit a record 84 last year, double the number of five years ago, IQVIA reported in its latest annual review of research and…

Members of FDA’s Oncologic Drugs Advisory Committee voted 14-1 yesterday to require a U.S. study for sintilimab, Lilly’s investigational lung cancer drug that — so far — only has Chinese…

A foundation representing German vaccine maker BioNTech has been accused of trying to undermine the World Health Organization’s (WHO) initiative to bring COVID-19 vaccine manufacturing to the African continent. Source:…