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

06:51 BST Lianhua Qingwen Capsule was included in the white list of anti-epidemic medicines in Uzbekistan

On August 11, 2020, the Ministry of Health of Uzbekistan released the Measures to Regulate the Circulation of Medicines, Medical Devices and Medical...


04 Aug, 2020, 04:30 BST Macrogen Obtains Europe's CE-IVD Certificate for its COVID-19 Test Kit

The Korean biotech company Macrogen (CEO Sukang Lee), announced on the 3rd that it had obtained the CE marking for Europe's In-Vitro Diagnostic...


30 Jul, 2020, 13:00 BST LimaCorporate Is The First Italian Company To Obtain The EU Quality Certificate Under The MDR

LimaCorporate announces that it is the first Italian company to obtain the EU Quality Management System certificate under the new European Medical...


29 Jul, 2020, 18:25 BST Henlius and Accord Healthcare Receive EMA Approval for Zercepac®, trastuzumab biosimilar

The European Commission (EC) has approved Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord)'s Zercepac®, a biosimilar...


27 Jul, 2020, 11:00 BST Rapid Medical Receives CE Mark for TIGERTRIEVER™ XL

Rapid Medical, a company focused on the development of next generation neurovascular devices, has announced that it received CE Mark for TIGERTRIEVER ...


24 Jul, 2020, 12:39 BST Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options

Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare...


15 Jul, 2020, 14:00 BST Pandemic Concerns Drive Gold Prices up 13% in Q2

Gold has historically been a safe haven during times of uncertainty and the markets are once again turning to gold in the face of the current global...


13 Jul, 2020, 14:00 BST Ovid Therapeutics and Angelini Pharma Enter into Exclusive License Agreement to Develop, Manufacture and Commercialize OV101 for the Treatment of Angelman Syndrome in Europe

Angelini Pharma obtains exclusive development, manufacturing and commercialization rights to OV101 (gaboxadol) for the potential treatment of...


13 Jul, 2020, 08:00 BST SINOMED® Completes One-Year Follow-Up of the PIONEER-III European, US and Japanese Trial of the BuMA Supreme® Coronary Drug-Eluting Stent

SINOMED, a developer of innovative neuro- and cardiovascular technologies, announced the completion of the 1-year follow-up in the PIONEER-III,...


07 Jul, 2020, 20:09 BST LaunchPad Medical Initiates its First European Clinical Study

LaunchPad Medical, Inc. announced that it has received approval from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to ...


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...


20 Jun, 2020, 15:46 BST Glenmark Becomes the First Pharmaceutical Company in India to Receive Regulatory Approval for Oral Antiviral Favipiravir, for the Treatment of Mild to Moderate COVID-19

In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, today...


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 ...