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FDA and EMA align on 90 percent of marketing authorisation decisions europeanpharmaceuticalreview
August 23, 2019
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
Submission and acceptance of application for the production of new drug for Yisaipu(R)aqueous injection solution prnasia
August 06, 2019
3SBio Inc. (01530.HK), a leading biopharmaceutical company in the PRC, announces today that an application for the production of new drug has been submitted to the National Medical Products Administration for ...
BioInvent Receives TAK-169 IND Application Milestone Payment americanpharmaceuticalreview
July 08, 2019
BioInvent announced it will receive a $0.5 million milestone payment related to the acceptance by the U.S.
Steriline products and solutions: Robotic applications europeanpharmaceuticalreview
May 22, 2019
Steriline products and solutions: Robotic applications.
Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA drugs
April 11, 2019
Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA.
Indian Government notifies new rules for drugs and clinical trials expressbpd
March 26, 2019
The new rules reduce the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
Service Rules en-cphi.cn
March 20, 2019
Client Service Officer: Miss. Liu Tel: 86-21-33392092 E-mail: Winnie.Liu@ubmsinoexpo.com
U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden =10 mut/Mb americanpharmaceuticalreview
June 27, 2018
ristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low
Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder drugs
May 31, 2018
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD).
Belgium’s Ablynx submits marketing authorisation application for caplacizumab approval pharmaceutical-technology
February 08, 2017
Belgium-based Ablynx has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for approval of caplacizumab anti-von Willebrand factor (vWF) Nanobody to treat acquired thrombotic thrombocytopenic purpura (aTTP).

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