The world of medicine has taken a significant leap forward with the first AI-generated drug entering clinical trials. This ...

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

Nimesh Khadka: Hot melt extrusion is widely used to improve drug solubility, bioavailability, and stability, but the process ...

The amendments will also enable the central drug regulator—Central Drugs Standard Control Organisation (CDSCO)—to optimise ...

In my previous article, I discussed how AI is rapidly transforming the drug discovery process, significantly accelerating timelines and reducing costs. However, while AI's potential in this domain is ...

Generative AI, once seen as a tool for writers and artists, is now reshaping the high-stakes world of pharma regulation.

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...