Tag: NDA

FDA Accepted NDA for Vertex’ Combo Treatment

Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combinat...

FDA Initially Rejected AZ’s NDA for Farxiga

The US Food and Drug Administration (FDA) has issued a complete response letter to AstraZeneca regarding the supplemental New Drug Application for Farxiga (dapagliflozin), meaning that the governing b...

EMA to Review MAA for First China-Developed Trastuzumab Biosimilar

First trastuzumab developed in China following the National Medical Products Administration (NMPA) technical guideline for biosimilar with the New Drug Application (NDA) received the acceptance for re...

FDA Accepted Boehringer, Lilly NDA for Triple Combination Tablet for Adults with Type 2 Diabetes

diabetes drugs
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended relea...

Bayer and Orion nmCRPC Drug Got Priority Review

Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration...

Celgene Sumitted NDA for Ozanimod

Celgene Corporation announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for ozanimod for the treatment of adults with relapsing forms of mult...

Priority Review for Celgene Myelofibrosis Med

Celgene Corporation today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for fedratinib and granted a Priority Review. Fedratinib is a high...

Priority Review for AbbVie’s NDA

abbvie office
AbbVie, a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitin...

Priority Review for Personilized Med of Genentech

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib f...

Latuda’s Positive Results for Patients with Schizophrenia

Japan-based Sumitomo Dainippon Pharma has published positive results from the phase III JEWEL trial into its drug Latuda (lurasidone hydrochloride) for patients with schizophrenia. The JEWEL study ...

FDA Accepted NDA from Kala for Dry Eye Disease Drug

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by Kala Pharmaceuticals for its KPI-121 0.25% product candidate. The FDA will review the NDA for KPI-12...