When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...

REGN scores FDA approval for Lynozyfic in tough-to-treat multiple myeloma, bolstering its oncology pipeline amid Eylea headwinds.

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...

The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.

On average, it costs $880 million to get a completely new medication through the FDA approval process. That number can easily surpass $1 billion if there are any issues with trials or data.

The Company’s announcement of FDA approval of the CGuard Prime Carotid Stent System triggers the second of four milestone-driven warrant tranches pursuant to the private placement financing of ...

Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine™ Dx Expr ...

Cue Biopharma receives positive FDA feedback on CUE-401, a novel T cell modulator for autoimmune disease treatment.

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These are the key takeaways.