Short Summary The EU, UK, and USA each have distinct and evolving regulatory systems for medicines and medical devices, involving strict approval, surveillance, and market access requirements managed ...

AI and automation are revolutionizing biopharmaceutical manufacturing by enhancing efficiency, improving quality control and ...

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.

For companies in the biotech space, it’s never been easy to navigate the legal and business risks inherent in a highly ...

The Managing Director of the Liberia Medicines & Health Products Regulatory Authority (LMHRA), Dr. Luke L. Bawo, has announced progress in finalizing a Public-Private Partnership (PPP) agreement to ...

Rare diseases, often referred to as orphan diseases, affect small patient populations, yet collectively they impact more than ...

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

CDMOs are crucial partners in alum-based vaccine production, managing aseptic filling with precision and efficiency.

Besides generics, Dr. Reddy’s has committed a lot of resources to develop its biosimilars as well as new chemical entity business. Biosimilars have been seen as a growth engine for large, capable ...

The regulatory body issued the directions after it found that certain FDC drugs have been licenced for manufacture, sale, and ...

In the ensuing years, the pharma supply chain will become even more complex, requiring increasingly agile and responsive logistics to support the development of personalized medicine. Sustainability ...

Vinopriya Vijayaboopathy has actually proven that the accuracy of forecasting in PBM may indeed boost into a strategic lever.