With the program’s seventh approval in the books, the FDA is illustrating just how speedy it can be with drug reviews that ...

Partner Therapeutics announced last week that the FDA had granted Bizengri a Commissioner’s National Priority Voucher to ...

Since it was established nearly a year ago by the FDA, the Commissioner’s National Priority Voucher (CNPV) program has been ...

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...

Sanofi has asked the FDA to pull its type 1 diabetes drug out of Commissioner Marty Makary’s new speedy drug review program.

A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies ...

WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...

Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. In a set of policy measures that aim to combine speed with cost ...

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