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

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 ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

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

The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September ...

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 ...

KalVista Pharmaceuticals, Inc. (KALV) announced Tuesday that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted ...