FDA moves to ban phenylephrine, found in dozens of popular cold medications, after research shows it performs no better than ...

The United States Food and Drug Administration (FDA) recently released a draft guidance, Expedited Program for Serious ...

Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational ...

NewsMedical speaks with CN Bio about the translatability between in vitro organ-on-a-chip (OOC) models, microphysiological ...

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) ...

In this week’s edition of InnovationRx, we look at Eli Lilly’s weight-loss pill stockpiling, scaling stem cell manufacturing, ...

A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...

The Food and Drug Administration granted fast track designation to AUTX-703 for relapsed or refractory acute myelogenous ...

Jeanne Shaheen, D-N.H., the ranking Democrat on the Appropriations Committee’s subcommittee on Agriculture, Rural Development ... They underscore that the FDA’s drug, device and tobacco ...

Biopharmas and global agencies are now prioritizing initiatives and innovations to drive speed across product development ...

Drug development is an expensive and high-risk process. The median cost per approved drug can reach up to $2.8 billion, ...

Initial feasibility study of its soluble, Ph neutral, fast acting granular or powder drug delivery system is complete ...