When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

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 ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

Adial Pharmaceuticals Inc. ADIL said Wednesday it has completed demonstration batch production for its lead candidate AD04, ...

The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or information that supports regulatory decision-making in ...

CHARLOTTETOWN, Prince Edward Island--(BUSINESS WIRE)--Today BIOVECTRA celebrates the completion of its $90 million plus biologics expansion at the company’s new state-of-the-art Biomanufacturing ...

This investment comes as LGM Pharma experiences sustained growth in prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The Rosenberg facility ...