The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, ...

As drug development enters a new era, Certara is expanding its global team of scientists and technologists to lead the shift toward AI-powered testing methods.

FDA announces major reforms to streamline biosimilar approvals, potentially saving Americans billions on prescription drug ...

Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to ...

The Lupus Research Alliance (LRA), through its Lupus Accelerating Breakthroughs Consortium (Lupus ABC)—a public-private ...

Since 2023, the U.S. Food and Drug Administration (FDA) has not required animal testing, thanks in part to organoids, which ...

American inspections of foreign food facilities — which produce everything from crawfish to cookies for the U.S. market — ...

Biosimilar developers should expect case-by-case evaluations, as the draft offers no hard rules on when CES will be waived. Developers are encouraged to consult the FDA early to understand evidentiary ...

Day Safety Update Submitted to FDA ORCA-OL Long-Term Safety Trial Successfully ConcludedDSMC Completes Final Review of Cytisinicline, Finds No Drug Safety Concerns SEATTLE and VANCOUVER, British ...

Vancouver, Canada, November 4th, 2025, FinanceWire Equity Insider News Commentary – The precision medicine sector reached ...

Company is winding down global enrollment for the RASolute 302 clinical trial studying daraxonrasib in patients with previously treated PDAC and ...

Copenhagen, Denmark, November 4, 2025, (GLOBE NEWSWIRE) - BioPorto A/S ("BioPorto” or the "Company”) (CPH:BIOPOR), today announced an update on its ongoing adult clinical study in the US.