Modular process design, single-use technologies, and flexible filling lines are some of the ways manufacturers can combat ...

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 ...

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

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

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

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

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

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

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on ...

In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for ...

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance ...