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

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

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

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its ...

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

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.

WuXi Biologics secures US FDA Pre-License Inspection approval for five facilities, first for commercial PFS line: Wuxi, China Wednesday, July 23, 2025, 13:00 Hrs [IST] WuXi Biolog ...

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.