Despite the Trump administration's shake-up of the agency, the US FDA is the first port of call for most ASX biotechs.

TLX007-CDx is a cold kit designed for the preparation of PSMA-targeted PET imaging for prostate cancer. It leverages ...

Telix Pharmaceuticals Limited today announces that the United States Food and Drug Administration has approved its New Drug ...

Gvoke VialDx is a concentrated liquid glucagon product. For diagnostic procedures, it works as a gastrointestinal motility inhibitor. The product is supplied as a single-dose vial containing 1mg of ...

The US Food and Drug Administration (FDA) has approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in ...

Regulatory and reimbursement pathways should consider indirect benefits in addition to direct health benefits when evaluating ...

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 ...

Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...

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

Attorney Simon Purnell of Griffin Purnell said he thinks the courts' view of preemption is a "fundamental misunderstanding of ...

Heart disease patients now have another treatment option. The U.S. Food and Drug Administration has approved Alnylam ...

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide ...