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

The FDA published their complete response letters to drug and biological product applications as part of an effort for more transparency.

For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

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

Amphix Bio, a company spun out from Stupp’s Northwestern laboratory, is helping navigate the FDA approval process and has received early feedback from the agency on the drug development program for ...

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.

For decades, above-the-knee amputees have had to live with stiff, uncomfortable prosthetics that felt more like rigid tools ...

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

The Food and Drug Administration (FDA) said Tuesday they are still processing the approval of vaccines intended to counter Dengue and African Swine Fever. During an ambush interview on Tuesday ...