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

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

The U.S. Food and Drug Administration (FDA) requested six-month safety exposure data to be included in the company's planned New Drug Application (NDA). Further ... successfully completed two Phase 3 ...

DURECT Corporation (Nasdaq: DRRX) today announced the publication of a peer-reviewed article on the AHFIRM trial data in NEJM ...

Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.

RenovoRx, Inc. ("RenovoRx" or the "Company") , a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared delivery platform, today ...

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA), a biopharmaceutical company announced on Monday, that it has accepted the FDA's offer for a hearing regarding its New Drug Application or NDA for ...

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

Auditor Diana DiZoglio in a scathing new report called the executive branch’s handling of employment settlements “dysfunctional” and “chaotic,” saying agencies failed to operate with ...

clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SL1009, Sodium Dichloroacetate Oral ...

NEW DELHI: The parliamentary committee scrutinising the Waqf bill on Monday adopted all amendments proposed by BJP members and negated those by opposition MPs. Opposition MPs proposed amendments ...