Tag: new drug application

August 19, 2019

Nabriva Notches First FDA Nod for Pneumonia Treatment

The FDA's approval of Xenleta is the first of its kind in almost two decades and will treat community-acquired bacterial...
July 3, 2019

RedHill Biopharma Receives FDA Acceptance for New Drug Application of Talicia

RedHill Biopharma (NASDAQ:RDHL) has announced that the US Food and Drug Administration (FDA) has accepted its Talicia new drug application...
May 17, 2019

Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch,

Agile Therapeutics (NASDAQ:AGRX) has announced it has resubmitted to the US Food and Drug Administration (FDA) its new drug application...
March 7, 2019

Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam to Treat Moderate-to-Severe Acne

Foamix Pharmaceuticals (NASDAQ:FOMX) has announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application...
February 19, 2019

Assertio Therapeutics Announces FDA Notification of Acceptance for Filing of 505(b)(2) NDA for Long-acting Cosyntropin

Assertio Therapeutics (NASDAQ:ASRT) has announced it has received notice of acceptance for filing from the US Food and Drug Administration...
January 30, 2019

GBT Announces Publication of Data from Phase 1/2 Study of Voxelotor in Patients with Sickle Cell Disease

Global Blood Therapeutics (NASDAQ:GBT) today announced that data from its Phase 1/2 study of voxelotor in patients with sickle cell...
January 4, 2019

Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous CONTEPO

Nabriva Therapeutics (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections,...