Ironwood Pharmaceuticals, Inc. IRWD announced that it has initiated the rolling new drug application (“NDA”) submission for ...

Labeling is based on the agency's thorough analysis of the new drug application (NDA) or biological license application. The labeling, or prescribing information, is thus subject to FDA ...

The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.

Pharmaceuticals announced a streamlined strategic focus on advancing and realizing the potential of apraglutide for the ...

In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...

Breakthrough Therapy Designation: a process that speeds up the development and review ... responds to treatment without their cancer growing or spreading. New Drug Application (NDA): a request to ...

CNS-focused biopharma Axsome Therapeutics has won US Food and Drug Administration (FDA) approval for Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in ...

has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. "There are more than 8 million patients living with schizophrenia in China who face significant ...

Vanda Pharmaceuticals (VNDA) provided an update on the tradipitant development program. Gastroparesis is a serious digestive disorder of the ...