The company already has two other cancer drugs approved – Adcetris (brentuximab vedotin) for certain forms of lymphoma and Padcev (enfortumab vedotin) for advanced bladder cancer. The FDA had ...

although that drug was already in late-stage development when the deal was struck towards the end of 2019. Now, Enhertu's approved as a third-line therapy for HER2-positive breast and gastric ...

Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce ...

Ernst emphasized the strategic transformation of Tivic into a diversified therapeutics company, combining biologic and bioelectronic approaches to address immune dysregulation. This includes ...

The conversion from accelerated approval to traditional approval was supported by data from the phase 3 KEYNOTE-811 trial.

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...

Alnylam Pharmaceuticals' amyloidosis drug Amvuttra received Food and Drug Administration approval for an expanded indication.

"FDA approves Johnson & Johnson’s Tremfya to treat Crohn’s disease" was originally created and published by Pharmaceutical ...

Amvuttra is now approved in the US to treat both cardiomyopathy and polyneuropathy manifestations of ATTR amyloidosis.

Scienture (SCNX) announces the U.S. Food and Drug Administration, FDA, has approved SCN-102, one of the products being developed by Scienture, ...

Kennedy Jr., has pledged to close a legal loophole that has enabled food companies to bypass approval by the Food and Drug Administration (FDA) when introducing new additives into their products.

Three months into his second term, President Trump hit the highest approval rating he’s ever had as commander-in-chief — while more Americans say the country is on the right track than at any ...