The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...

Two Nebraska researchers have launched a startup company aimed at bringing to market an innovative method for delivering therapeutics, gene editing tools, plasmids and more to targeted locations in ...

Scientists have taken a major step forwards in tackling one of the greatest abiding challenges in chemistry, by learning how to program the self-assembly of molecules in such a way that the end result ...

California is not one of those states. Newsom in October rejected a $35 monthly insulin copay cap. In his veto message, he cited the state’s $100 million investment in insulin production as an example ...

The New Brunswick, N.J., pharmaceutical giant said the FDA accepted the application through its Real-Time Oncology Review program, which allows for an earlier submission of topline efficacy and safety ...

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some ...

The development of new drugs is critical in treating cancer—if people have access to them. A team co-led by Penn State ...

A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...

The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.

A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could revolutionize the drug industry. The safer, cheaper, more environmentally friendly ...

Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage.