US FDA's Breakthrough Program Needs Higher Standard For Comparators, NEJM Says

12 Apr 2018

• By Michael Cipriano

Harvard Medical School researchers call for inclusion of off-label drugs, accelerated approvals, and dietary supplements in the definition of 'existing therapies.'

Three Harvard Medical School researchers are calling for the US FDA to broaden the definition of "existing therapies" in the criteria for the breakthrough therapy designation to raise the comparison baseline and increase the bar to qualify for the designation.

In a study published in the New England Journal of Medicine (NEJM) on April 11 that examines the first four...

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Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

24 Jul 2025

• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

24 Jul 2025

• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.