Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

When smart people make irrational choices, we often assume they are acting out of selfishness, stupidity or stubbornness.

From the beginning, the approval of its Aduhelm (aducanumab) treatment was met with controversy – over the interactions with the FDA, and the advisor committee’s vote against the treatment ...

Learn more about whether Biogen Inc. or Neurocrine Biosciences, Inc. is a better investment based on AAII's A+ Investor grades, which compare both companies' key financial metrics.

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

The FDA gave Aduhelm an accelerated approval, meaning that Biogen has to carry out a post-marketing trial to confirm that it is effective, but critics say results from that will be years away.

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...