Evolving trade policies and tariffs strain bio/pharmaceutical manufacturers, affecting profits and operational strategies.

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse ...

If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.

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

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.

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

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

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

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

In this podcast episode, we discuss sustainable approaches to such equipment and materials as medical propellants, flow sensor technology, and walk-in chambers, plus the critical role of women in ...

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