Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and ...

The two companies have entered into an agreement to develop respiratory, immunology, inflammation, and cancer therapies.

Re-Vana’s drug delivery technology is designed to release treatments over a 6- to 12-month period, with the goal of reducing ...

EMA encourages NAMs to replace animal testing, aligning with 3Rs principles, and has published a concept paper on regulatory ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

The company will build a multi-billion-dollar drug manufacturing center in Virginia that will focus on chronic diseases, as ...

While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as ...

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava ...

Brian Bosso is technical services manager, STERIS.The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process ...

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than ...