Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...

Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

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 ...

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...

Simulations Plus is a specialized in silico software-and-services platform. They help with model-informed, non-animal drug development. SLP’s services help across discovery, development, and clinical ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

FRANKFURT, Germany--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, will showcase its latest flexible solutions to help boost efficiency and scale in ...

A new project seeking to transform the drug delivery process and take projects out of “the valley of death” between aspiration and accomplishment is getting help from La Jolla-based medical research ...

Forbes contributors publish independent expert analyses and insights. Gil Press writes about technology, entrepreneurs and innovation. Will AI transform the typical trials and tribulations of drug ...

IQVIA Holdings is positioned as the indispensable data and technology backbone of the life sciences industry, far beyond a traditional CRO. Long-term revenue visibility is underpinned by a record ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...