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The drug regulatory landscape in China: Progress and Reform Deborah Seah
April 20, 2023
Since 2015 when drug approval policies and process have begun its reform, China has seen improvements in both the speed and predictability of drug approvals over the past few years.
Weekly Pharma News Review | PharmaSources.com (March 28 to April 1) PharmaSources.com
April 07, 2022
The failure of Phase III clinical trials targeting the popular target TIGIT monoclonal antibody has once again put tumor immunotherapy on the radar this week. The pharma news review of this week from March 28 to April 1 covers a total of 25 pieces of news
Advancing Generic Drug Development to Approval Lin Zhang
October 22, 2021
The FDA continuously works to change and improve their work, including the work done with generic drugs. Last month, September 21-22, 2021, the Food and Drug Administration (FDA) hosted a workshop...
Polpharma Biologics Announces Approval of Europe’s First and Only Biosimilar for Multiple Sclerosis - Tyruko® (Natalizumab) B3C newswire
November 06, 2023
Polpharma Biologics, today announced that the European Commission (EC) has approved Tyruko® (natalizumab) as the first and only biosimilar for relapsing forms of multiple sclerosis (MS) in Europe.
Numbers of Drug Approval by FDA, EMA and NMPA in 2019 En-CPhI.Cn
January 23, 2020
A quick review of drug approval in the past 2019 by NMPA, EMA and FDA.
FDA Approves First Single-Tablet, Two-Drug Treatment for Untreated HIV drugs
April 10, 2019
FDA Approves First Single-Tablet, Two-Drug Treatment for Untreated HIV
The novel drugs marketed in 2018 PharmaSources/1℃
January 03, 2019
The attached table includes the novel drugs marketed in 2018.
AstraZeneca, FibroGen give China bragging rights to first-in-class anemia drug approval fiercepharma
December 26, 2018
It is a rare event, if not a singular one in the biopharma world: A first-in-class drug developed by multinational pharma companies was filed first—and now approved first—in China, well before the U.S., EU or Japan.
Shire gears up to battle Allergan's Linzess with new constipation drug Motegrity fiercepharma
December 19, 2018
Takeda is set to gulp up Shire, whether disgruntled investors like the deal or not. But for those in the latter camp, the biotech’s latest approval may make it easier to swallow.
On a roll with FDA approvals, Pfizer doubles down in AML with Daurismo nod fiercepharma
December 10, 2018
Make that four drug approvals for Pfizer’s oncology unit in less than two months. In a welcome streak for the pharma giant—what with Lyrica generics looming—the FDA handed out

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