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

FDA Policy Changes Could Bring Some Biosimilars To Market Faster. Legal News and Analysis - USA - Intellectual Property - Conventus Law ...

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.

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

The agency might dissuade patients from participating in a crucial part of our research-and-development system.

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 ...

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

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

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 ...