FiercePharma

PharmaEngine Announces Filing New Drug Application (NDA) of MM-398 (PEP02) to Taiwan FDA as a Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer

TAIPEI, May 31, 2015 -- PharmaEngine, Inc. (TWO:4162) today announced that a New Drug Application (NDA) has been submitted to the Taiwan Food and Drug Administration (TFDA) for MM-398 (irinotecan ...
RAPS

Asia Regulatory Roundup: China’s NDA Revises Device Classification Requirements, Floats Changes to Imports

China’s National Drug Administration (NDA) has implemented a new classification system for medical devices. The new classification came into force on 1 August, moving China into a transition period ...
FiercePharma

Nippon Shinyaku Submits NDA to MHLW for Selexipag for Treatment of Pulmonary Arterial Hypertension.

Nippon Shinyaku Co., Ltd. today announced the submission of the New Drug Application (NDA) for selexipag (development code: NS-304), which was originally discovered and synthesized by Nippon Shinyaku ...
아시아경제

HLB Applies for FDA Pre-NDA Meeting for Biliary Tract Cancer Drug, Initiates New Drug Approval Process

On July 30, HLB announced that its U.S. subsidiary, Elevar Therapeutics, has applied for a pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA) in preparation for ...