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

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 ...

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

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

The U.S. Food and Drug Administration has approved GSK's prefilled syringe presentation of Shingrix (zoster vaccine ...

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

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...

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

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.

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

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.

'FDA approval' has a certain glow of authority to it—but it's not always well-founded. ... Giving snake oil peddlers an FDA registration is like handing them a shiny plaque to display on their wall.