The United States Food and Drug Administration (FDA) recently released a draft guidance, Expedited Program for Serious ...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

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

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

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

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

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 ...

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

Washington — Federal officials on Thursday approved a new type of pain drug designed to eliminate ... medication's modest effectiveness and lengthy development process underscore the challenges ...

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

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

RFK, Jr.'s Health and Human Service has inexplicably cancelled two vaccine-related advisory meetings since he took the helm ...