Evolving regulations in sterile manufacturing requires innovation, market knowledge, and investment. How can drug ...

With its active pharmaceutical ingredient (API) facility “in a state of disrepair,” manufacturer Aspen Biopharma Labs’ operations have ground to a halt in the U.S., according to a recent FDA reprim | ...

While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models ...

DevOps and CSV form a powerful duo that, with strategic implementation, promises to propel the pharmaceutical industry.

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I CDMO growth strategy.

Created in 1992, the FDA's accelerated approval pathway allows an initial approval of drugs for serious or life-threatening ...

Learn more about whether Medpace Holdings, Inc. or Repligen Corporation is a better investment based on AAII's A+ Investor ...

Arialief offers a satisfaction guarantee, allowing customers to try the product risk-free. If users do not experience the ...

The 6-month room temperature stability on this batch adds to the nine-month data accumulated on a previous batch produced by ...

The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

Evofem Biosciences, Inc. (OTCQB: EVFM) (Evofem or the Company) today announced that it has entered into a License and Supply ...