In recent years, the Food and Drug Administration (FDA) has struggled with an increasing number of disagreements among its scientific staff. Many of these disputes have spilled out into public view.

In June 2025, the US Food and Drug Administration (FDA) announced the Commissioner's National Priority Voucher (CNPV) pilot programme. The regulatory framework allows biotechs and pharma companies who ...

July 22 (Reuters) - Biotech experts and industry executives are calling plans by the U.S. Food and Drug Administration — hit by job cuts last year — to hire thousands of employees and update ...

Biohaven Ltd. ( BHVN) announced that the U.S. FDA has accepted for review the company's resubmitted New Drug Application (NDA) for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia, a ...

The US Food and Drug Administration (FDA) has released a call for comments on a new transparency and drug review program contained within the Prescription Drug User Fee Act V (PDUFA V), which is ...

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...

The Food and Drug Administration (FDA) won’t publish its safety review of the abortion drug mifepristone until March, it disclosed in a Wednesday court filing, adding that it won’t impose any new ...

The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients’ access to new ...

The FDA faces a court-ordered deadline today to update a federal judge in Louisiana on the status of its ongoing review of the abortion drug mifepristone, potentially shedding light on a secretive ...

Biotech investors want regulatory predictability More than 3,000 FDA jobs were cut by DOGE FDA now authorized to hire 2,200 employees Trump administration weighs three candidates to head FDA July 22 ...