The decision follows a pattern of policy shifts, including the rollback of COVID-19 recommendations and cancellation of mRNA funding.

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its ...

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...

The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical and ...

The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...

The Health Ministry proposes draft amendments to remove provisional registration for ethics committees, aiming to streamline clinical research approvals and cut regulatory delays ...

The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after prior targeted treatment.

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications. By the end of the ...

Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet ...