News by subject: IMA

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....

In an announcement published by Yiling Pharmaceutical on Tuesday, it is disclosed the enterprise has received the herbal product license for Lianhua Qingwen Capsules from the Pharmacy and Poisons Board of the Ministry of Health of Kenya. Kenya is the...

Amplience, the leading commerce experience platform for high scale, high growth brands and retailers, has announced significant global expansion of its partnerships over the last 12 months from 30 to 50 partners. Against the backdrop of the pandemic...

FUJIFILM Europe GmbH received the CE certificate and thus able to apply the CE mark to and launch an antigen test kit for diagnosis of SARS-CoV-2* infection. Fujifilm is using its proprietary silver amplification...

CLEW announced that it has registered its AI-powered ICU clinical management and support solution for CE, marking the company's further expansion into the European healthcare market. Registration of the full range of CLEW's advanced, AI-based...

Digital biomarker and medical device company Empatica is awarded CE-certification for its Aura system to detect and alert to respiratory infections, including COVID-19, early and before visible symptoms appear. Empatica received its CE mark as a...

Digital biomarker and medical device company Empatica is awarded CE-certification for its Aura system to detect and alert to respiratory infections, including COVID-19, early and before visible symptoms appear. Empatica received its CE mark as a...

Novogene Europe, a leading provider of genomic services and solutions, has announced the launch of a Clinical Service to provide its European customers with next-generation sequencing (NGS) services and solutions for their clinical samples. The...

Today, Health Canada authorized the COVID-19 vaccine manufactured by Janssen Inc. Health Canada received an application from Janssen Inc. for authorization of its COVID-19 vaccine on November 30, 2020. After a thorough, independent review of the...

Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada issued a Notice of Compliance for an alternative initiation regimen for ABILIFY MAINTENA® (aripiprazole for prolonged release injectable...

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, today announced that the European Medicines Agency (EMA) has completed a remote Pre-Approval Inspection (PAI) on its drug substance...

We are advised by Russian Direct Investment Fund (RDIF) that journalists and other readers should disregard the news release, "RDIF: Sputnik V approved for use in Slovakia" issued earlier today over PR Newswire, as distribution was not approved by...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the registration of the Russian Sputnik V vaccine against coronavirus in the Slovak Republic. Thus Slovakia has become the 39th country in the world and the second...

INVO Bioscience, Inc. , a medical device company focused on commercializing the world's only in vivo Intravaginal Culture System (IVC), INVOcell®, an effective and affordable treatment for patients diagnosed with infertility, today announced the...

Harbour BioMed (HBM) (HKEX: 02142) today announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for HBM4003, the next generation anti-CTLA-4 antibody in combination with...