The FDA doesn’t want any part of regulating the “sanitation tunnels” that have popped up in certain commercial settings as a response to the COVID-19 pandemic. Source: Drug Industry Daily

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

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:…