The FDA is phasing out animal testing and moving to more human-relevant methods. This was announced as one of Marty Makary’s ...

The U.S. Food and Drug Administration (FDA) has approved Ferring Pharmaceuticals’ drug product manufacturing hub in ...

The US Food and Drug Administration (FDA) has approved bevacizumab-nwgd (Jobevne, Biocon Biologics Ltd), a biosimilar to bevacizumab (Avastin, Genentech), for intravenous use across multiple cancer ...

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to develop life-saving medicines.

The nonprofit Physicians Committee for Responsible Medicine, which promotes the use of human-relevant test methods to replace ...

The US Food and Drug Administration ... to learn a new method of administration can be a game changer in increasing patient access to adalimumab.” The designation comes less than two weeks after the ...

Chime Biologics, a leading global CDMO that enables its partners’ success in biologics, announced a strategic cooperation agreement with Polpharma Biologics to advance the end-to-end development and ...

Sandoz sues Amgen in U.S. court over Enbrel patents, alleging efforts to block biosimilar Erelzi and delay competition in the ...

To get FDA approval, scientists must be able to demonstrate that a new drug or treatment is safe and effective. And currently, before they can test a new therapy in humans, they must show proof ...

AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic ...

Chime Biologics, a leading global CDMO that enables its partners' success in biologics, is pleased to announce a strategic ...