The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

Vienna, Austria – May 9th 2025 – Biomay, a leading manufacturer of recombinant proteins, today announced the commercial availability of its CRISPR/Cas9 nuclease, marking a significant addition to its ...

Donald Trump has promised to create a pro-AI environment, but even tech companies are frustrated by federal cuts that hamper regulatory processes. Paul Webster reports.

Because price and margin headwinds exist predominantly in small-molecule oral tablets that are easy to produce, we expect Viatris’ future pipeline to focus more on complex generics—drugs that have ...

The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

An analysis from IQVIA found that between 2017 and 2021 the U.S. spent $260 billion on originator biologics, 2 the reference ...

No, red dye 3 and red dye 40 are not the same. Red dye 40, made of a chemical compound called Allura red AC, is already banned in California, and is among the dyes that the FDA plans to eliminate, ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...