Judge Pauline Newman has served with distinction on the U.S. Court of Appeals for the Federal Circuit since her appointment ...

Mumbai: Piramal Pharma Solutions, a global Contract Development and Manufacturing Organization (CDMO) and part of Piramal ...

The shift towards sustainability in drug development focuses on reducing lab waste and enhancing operational efficiency for a ...

“The best ideas in drug discovery were often blocked not by biology, but by synthesis,” Boiko told TechCrunch. Synthesis is ...

Instead of requiring personalized gene edits for each patient, the new approach could create a standardized method to use for ...

The U.S. Food and Drug Administration (FDA) has granted fast track designation to DPTX3186, a first in class oral condensate ...

The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting ...

A spokesperson for the FDA said the agency is “considering a wide range of options to support American innovation." ...

The Inflation Reduction Act (IRA) of 2022 mandates price negotiations for certain drugs under Medicare, shortening the exclusivity period historically used to recoup research and development ...

The CNPV program aims to reduce drug review times to 1-2 months, raising concerns about safety and regulatory scrutiny. Critics argue that accelerated timelines may lead to safety issues and strain ...

Hackensack Meridian Health and Johns Hopkins University are launching a consortium with big pharma to expedite the ...

Moderna's $140 million investment in Norwood, Massachusetts, aims to complete its U.S. manufacturing loop, enhancing ...