GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

Atara Biotherapeutics Inc (NASDAQ:ATRA) saw its stock jump 7% following the U.S. Food and Drug Administration’s acceptance of ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

Ultragenyx's UX111 gene therapy faces FDA delay due to facility issues; analysts adjust price targets amid uncertain ...

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...

The FDA's decision to fully license the Pfizer-BioNTech COVID-19 vaccine is likely to trigger more mandates and allow marketing of the shot.

A high-pressure ventilator developed by NASA engineers and designed to treat COVID-19 has received FDA approval via a fast-tracked emergency use authorization.