As lightning-quick vaccine development comes close to catching up with a runaway pandemic, FDA must quickly decide how it will respond to the first clear signs that a vaccine candidate may be effective.  ...

President Donald Trump’s treatment with an investigational drug from Regeneron resurfaces long-standing ethical quandaries involving compassionate use and the allocation of scarce drugs. The REGN-COV2...

There will be no turning back to business as usual for drug developers and regulators after COVID-19, according to Bill Anderson, CEO of Roche Pharmaceuticals. But while he’s optimistic about speeding up timelines and changing...

After pledging up to $2.1 billion to a preclinical vaccine from Sanofi and GSK, the U.S. government’s total commitment for COVID-19 vaccine candidates now stands at $8.3 billion across seven vaccines based on four different...

The U.S. is trying to fight a 21st century pandemic with prehistoric clinical trials -- and achieving the kind of efficiency you might expect. In the last six months, tens of thousand of patients have...

Operation Warp Speed, along with its promises and dangers, is coming into sharp focus. Its investment of up to $1.2 billion in a COVID-19 vaccine candidate is testimony to the risks it is prepared to...

The U.S. government is laying plans to harness its buying power and applied research capabilities to pull influenza vaccine development and manufacturing into the 21st century. The goals are to enhance protection against seasonal flu,...

At the leading edge of drug development, digital health is starting to make waves, bringing products and tools that offer patients a new level of personalized medicine. At the same time, these technologies give the...

bluebird bio could be the first company to test an outcomes-based pricing model for a gene therapy where the vast majority of the price is at risk. On Friday, bluebird bio Inc. (NASDAQ:BLUE) announced the...

A June 5 Senate Finance Committee hearing saw sparks fly over allegations of spying, with two Republican senators accusing the Chinese government of engaging in large-scale espionage against U.S. taxpayer-funded research, and a Democrat countering...