The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...

The FDA said it proposed significant changes to simplify biosimilarity studies and reduce what it described as unnecessary ...

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

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 ...

The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed ...

The United States has said it will speed up approval for some generic drugs. The development comes weeks after it was ...

Biologic medications, while accounting for only 5% of U.S. prescriptions, represent 51% of total drug spending in 2024. Despite FDA-approved biosimilars being as safe and effective as their branded ...

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for ...

The FDA’s new draft guidance aims to make the approval process faster and less burdensome by limiting the need for ...