International Medical Approval The latest news regarding applications for approval and other processes from medical regulatory bodies around the world. This section contains releases relating to consideration of new products, drugs, therapies and treatments.

Latest

03 Jul, 2020, 07:30 BST IDELVION® Becomes First and Only Factor IX Therapy with 21-Day Prophylactic Dosing

Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) has approved the new Summary of Product...


02 Jul, 2020, 10:00 BST HeiQ Viroblock Certified as Cosmetic Grade and Bio-based Renewable

Textile innovator HeiQ's antiviral textile technology, HeiQ Viroblock NPJ03, has been certified as safe and sustainable as all its ingredients are...


29 Jun, 2020, 13:00 BST PTC Therapeutics Announces CHMP Recommendation of Translarna™ (ataluren) Label Update for Non-Ambulatory Patients with Duchenne Muscular Dystrophy

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...


26 Jun, 2020, 08:00 BST Philogen Received Clinical Trial Authorisation With Nidlegy in Nonmelanoma Skin Cancer

Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that the Swiss national competent authority Swissmedic issued the...


25 Jun, 2020, 11:43 BST IIoT and 3D Printing Propel Growth for North American Industrial Valve Makers amid Volatile Market

Frost & Sullivan's recent research, Analysis of the North American Industrial Valves Market, Forecast to 2026, predicts that this market will reach...


24 Jun, 2020, 08:00 BST Philogen Received Combination Pack Approval for Nidlegy

Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that, on Jan. 30, 2020, EMA's CHMP expressed a favorable opinion to...


18 Jun, 2020, 17:38 BST AceCann Receives Medical Cannabis Pre-license From Portuguese Regulator

AceCann, a Portuguese medical cannabis company focused on the cultivation, processing, extraction and R&D of organic medical cannabis, has achieved a ...


16 Jun, 2020, 07:44 BST SciBase Submits Reimbursement Application and Targets 2021 for First Reimbursement Coverage in the US

SciBase, a global healthcare company with a platform technology enabling innovative products for skin disorders such as skin cancer and atopic...


16 Jun, 2020, 01:00 BST WuXi Biologics (Suzhou) Received EMA GMP Certificate for Biosafety Testing

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that its facility in...


08 Jun, 2020, 08:00 BST First Adjuvanted Quadrivalent Influenza Vaccine by Seqirus Receives EU Approval

The European Commission has today given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become available across Europe....


05 Jun, 2020, 12:00 BST OPTI Medical Systems Receives CE Mark for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19

OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), today announced that it has received the CE mark certification...


02 Jun, 2020, 09:00 BST Lunit INSIGHT MMG, an AI Solution for Breast Cancer Detection, Now CE Certified

Lunit today announced that its AI solution for breast cancer, Lunit INSIGHT MMG, has been CE certified. The medical software was certified on May...


01 Jun, 2020, 12:00 BST Akcea announces approval for reimbursement of TEGSEDI® (inotersen) in Portugal for treatment of hereditary transthyretin amyloidosis with polyneuropathy

Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., today announced the Portuguese Medicine...


01 Jun, 2020, 07:00 BST Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab)

Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced that the Committee for Medicinal Products for Human ...


27 May, 2020, 06:00 BST Daewoong Pharmaceutical Acquires Halal Certification for 'Easyef' through Daewoong Infion

Daewoong Pharmaceutical (CEO Sengho Jeon) announced on May 25 that the Indonesian joint venture Daewoong Infion (CEO Chang Woo Suh) obtained Halal...


26 May, 2020, 13:25 BST Bardy Diagnostics® Announces CE Mark Certification for 14-Day Carnation® Ambulatory Monitor (CAM®) Patch in Europe and Expansion of Home Enrollment Program Amidst COVID-19 Crisis

Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it...