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

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 ...

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 ...

One Source Nutrition, Inc. is voluntarily recalling all of its Vitality male enhancement capsules nationwide after an FDA ...

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

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

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 ...

The U.S. health secretary has vowed to close an FDA loophole that has allowed food companies to self-police the safety of new ...

Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties ...