The approval pertains to the abbreviated new drug application (ANDA) for Selexipag injection at a strength of 1,800 mcg/vial.

announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Empagliflozin, Linagliptin and ...

On its way to tackle cancer therapy resistance with its monoclonal antibody visugromab, CataLym completes a $150 million ...

Treats were recalled after it was discovered product containing hazelnut was distributed in packaging that did not reveal the ...

What if there was a way to peer into your body and spot early signs of cancer and other life-threatening ailments before they ...

Potential malfunctions after implantation can cause disruption in therapy; some patients may need revision surgery.

For the first time ever, the federal government is seriously considering covering digital therapy tools through Medicare.

Zai Lab Limited (ZLAB) and argenx (ARGX) announced that China's National Medical Products Administration or NMPA approved the Biologics License Application or BLA for efgartigimod alfa injection ...

Health campaigners have written to U.S. regulators accusing Philip Morris International of misrepresenting past regulatory ...

Buldak spicy noodles are back on shelves in Denmark after the food authorities there canceled part of their recall decision concerning the famous Korean instant noodles product, originally issued due ...

VYVGART (efgartigimod alfa injection) is a human IgG1 antibody fragment that binds to the neonatal Fc reeptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first ...

Researchers found that adherence and persistence in T2D patients using oral semaglutide is similar to DPP-4i, but semaglutide ...