Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...

Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...

Ahead of Rare Disease Day, Abigail Beaney spoke with Robert Barrie and Frankie Fattorini on recent developments in the rare disease space.

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...

New FDA guidance on the use of antibiotics in food-producing animals has prompted criticism that it fails to consider the impact on human health.

In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...