News by subject: IMA

OrbusNeich® Medical Company Ltd. and P&F Products & Features®, under the joint partnership OrbusNeich P&F, today announced that the TricValve® Transcatheter Bicaval Valves System has received CE mark approval. The TricValve® Transcatheter Bicaval...

LifeSignals Inc., today announced the CE (Conformité Européene) Mark for the LifeSignals LX1550E Multiparameter Remote Monitoring Platform ? which can be used by clinicians for the continuous collection of physiological data of patients at home and...

CorVent Medical, a private medtech company focused on developing versatile, lifesaving ventilators for critical care, announced that it has received CE Mark approval and is ready to launch commercial use of its RESPOND-19tm Ventilator in Europe. The...

Abbott  today announced it has received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitortm, making the minimally invasive device available for people in Europe with severe aortic stenosis who are at...

Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, announced today that the China National Medical Products...

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology,...

Johnson & Johnson (the Company) today announced the World Health Organization...

Materia, a medical cannabis and wellness company focused on the European market, today announces that its wholly-owned subsidiary Materia Malta Operating Ltd. ("Materia Malta" or the "Company") has received its European Union Good Manufacturing...

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology,...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that HyBrytetm (hypericin) was awarded...

Transit Scientific announced it received CE Mark clearance in the European Union for the XO Score® Scoring Sheath Platform to facilitate dilation of stenotic material in the peripheral vasculature including popliteal, infrapopliteal, and native or...

A saliva collection kit that uses a pain-free method to test for COVID-19 is being distributed in Europe for the first time by RxBIO, a leading medical device distribution company. Spectrum Solutions' SDNA saliva collection kit offers a comfortable...

Amgen Canada today announced that AMGEVITA® (adalimumab, reference biologic drug: Humira®), is now available in Canada for the treatment of 11 chronic inflammatory conditions....

Oculogica, a medical device company and leader in concussion diagnosis and categorization, announced today the Therapeutic Goods Administration (TGA) of Australia granted approval to its EyeBOX technology. The test is for both pediatrics and adults....

Eli Lilly and Company announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Lilly is offering...

Galmed Pharmaceuticals Ltd. ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the National Medical Products Administration (NMPA) has granted approval for the...

With the official release and implementation of the Overall Plan for the Construction of Hainan Free Trade Port, patient can now access global innovative medicines in mainland China. Recently, the global first-in-class selective inhibitor of nuclear...

Syqe Medical®, a leading global pharma-tech company, announces today that Health Canada has approved the Syqe® Inhaler, the first pharmaceutical grade medical cannabis delivery device system that provides predictable and consistent dosing through...

OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) and Veloxis Pharmaceuticals Inc., a subsidiary of Asahi Kasei, today announced a global license agreement granting Veloxis Pharmaceuticals worldwide rights to develop, manufacture and...

Karyopharm Therapeutics Inc. , a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Company's Type II Variation Marketing Authorization Application...

A new interventional solution from China for structural heart disease is about to be launched onto the market. Recently, TaurusOne® Transcatheter Aortic Valve Replacement System (hereinafter referred to as "TaurusOne®") developed by Peijia Medical...

A new interventional solution from China for structural heart disease is about to be launched onto the market. Recently, TaurusOne® Transcatheter Aortic Valve Replacement System (hereinafter referred to as "TaurusOne®") developed by Peijia Medical...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high...

A GLOBAL sarcoma therapy shown to improve progression free survival1 has been approved for Australian patients by the country's peak medicines regulatory agency. The Therapeutic Goods Administration has approved the...

Johnson & Johnson (the Company) today announced that the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company's COVID-19 vaccine and confirmed the overall...

Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company has fast-tracked the marketing and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN®) under "US FDA 'Enforcement Policy for...

Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has granted EVRYSDI? (risdiplam) market authorization for the treatment of spinal muscular atrophy (SMA) in patients...

OncoSec Medical Incorporated (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, today announced that it has received authorization to CE mark its proprietary next generation go-to-market...

Covid-19 is an infectious disease that may lead to Acute Respiratory Distress Syndrome (ARDS) and respiratory dysfunction (Liu 2017).  Science recognizes that Covid-19 ARDS' excessive mortality rates are due to the medical establishment's inability...

Technomed, a provider of medical technology solutions and products, has released the world's first COVID-19 antigen-rapid self-test for use throughout the UK. This new product will directly support the UK government's strategy for all UK adults to...

Zentiva and mAbxience announce their collaboration for the launch of the ALYMSYS® (bevacizumab) following its European Marketing Authorisation on March 26th. The EC approval is based on a comprehensive clinical and scientific package which...

CanSino Biologics Inc. ("CanSinoBIO") (HKEX: 06185) today announced that the Instituto de Salud Pública de Chile ("ISP") granted emergency use authorization for its Recombinant...

EyeYon Medical, an Israeli start-up company developing a variety of ophthalmic products for vision-threatening conditions, announces today that EndoArt® was granted the Innovative Device Status by China's Center for Medical Device Evaluation, the arm...

Abbott today announced its XIENCE stent has received CE Mark in Europe for shorter duration of dual anti-platelet therapy (DAPT) ? as short as 28 days, the shortest indication available in the world ? for patients with high bleeding risk (HBR). The...

HUYABIO International (HUYABIOtm), the leader in accelerating global development of China's pharmaceutical innovations, today announced the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000...

Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), a global biopharmaceutical company, today announced that the European Medicine Agency (EMA) Committee for Orphan Medicinal Products granted orphan drug...

Neurophth Biotechnology Ltd., a fully-integrated genomic medicines company developing adeno-associated viral (AAV)-delivered gene therapies for the treatment of ocular diseases, recently announced the Center for Drug Evaluation (CDE) of China...

The European Commission (EC) has approved mAbxience's MB02 biosimilar to Avastin® (Bevacizumab), in Europe. MB02, to be commercialized as Alymsys® and Oyavas®, is highly similar to the reference medicinal product and data has shown a comparable...

The European Commission (EC) has approved mAbxience's MB02 biosimilar to Avastin® (Bevacizumab), in Europe. MB02, to be commercialized as Alymsys® and Oyavas®, is highly similar to the reference medicinal product and data has...

SK Biopharmaceuticals, Co., Ltd., a global innovative pharmaceutical company, announced today that cenobamate received marketing authorization from the European Commission (EC) under the brand name ONTOZRY® for the adjunctive treatment of focal-onset...

Angelini Pharma, an international pharmaceutical company part of the privately held Italian Angelini Group that has recently acquired the biopharmaceutical company Arvelle Therapeutics, announced today that the European Commission (EC) has granted...

PTC Therapeutics, Inc. today announced that the European Commission (EC) has granted marketing authorization to Evrysditm (risdiplam) for the treatment of spinal muscular atrophy (SMA) in patients 2 months and older. Evrysdi will be for SMA Type 1,...

Karyopharm Therapeutics Inc. , a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Commission (EC) has granted conditional marketing authorization for NEXPOVIO (selinexor), the Company's...

NLS Pharmaceutics Ltd. ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that it...

PARI Pharma GmbH, a company focused on advanced aerosol delivery systems based on eFlow Technology, announces the authorization of the LAMIRA Nebulizer System for delivery of Insmed's drug product ARIKAYCE (amikacin liposome inhalation suspension) in...

Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, today announced approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the first and only vision correction...

Insmed Incorporated , a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved ARIKAYCE® (amikacin...

Marks vaccine's first approval by an European Union member state, following Mexico, Pakistan and China Continues to boost production capacity to meet increasing demand Safe, stable storage and transportation between 2°C and 8°C, accessible by...

Seqirus, a global leader in influenza prevention, announced that Health Canada has approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), its cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age...

Transit Scientific announced it received CE Mark approval in the European Union for its non-tapered metal alloy XO CrossÒ Microcatheter platform....