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 NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.

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 ...

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 ...

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 ...

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 ...