News by subject: IMA

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...

DUPIXENT® is the only biologic medicine approved to treat atopic dermatitis for this patient population. Fifth indication for DUPIXENT® in Canada following approvals for moderate-to-severe atopic dermatitis in adults and adolescents, severe chronic...

Curocell, Inc., a clinical-stage biotech developing next-generation CAR-T (OVIStm) therapies, announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved its Phase 1/2 clinical study application for CRC01, CD19 CAR-T cell therapy...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the approval of the Russian Sputnik V vaccine against coronavirus by the Ministry of Health of the Republic of San Marino ? the world's oldest constitutional...

HADLIMA® is a biosimilar biologic drug (biosimilar) to the reference biologic drug HUMIRA®. A biosimilar is authorized based on its similarity to a reference biologic drug that was already authorized for sale.1 Approximately six million Canadians...

Vax-Immune Diagnostics announces today it has received CE Mark approval for its first-in-class medical device, LabReady® GBS. LabReady's Group B Strep product is the first in Vax-Immune Diagnostics' lineup of women's health solutions that helps avoid...

Johnson & Johnson (the Company) today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisation for its investigational...

Private payer health plan coverage in Canada for Vascepa is expected to reach more than 80% by the end of February 2021, up from 50% in November 2020 Coverage effective for statin-treated patients with elevated triglycerides, who are at high risk of...

LimaCorporate makes important strides in the development of its digital platform designed to assist surgeons in delivering improved outcomes with an accessible and sustainable economic model, following the milestone-based acquisition of TechMah...

Q'Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today it has raised $22 Million in Series C funding. The round included...

Insightec®, a global healthcare company focused on creating the next generation of patient care, announced it received market approval by The National Medical Products Administration (NMPA), the Chinese agency for regulating drugs and medical devices...

Ava, a digital healthcare company focused on women's reproductive health, announced today it has received FDA clearance for its Ava Fertility Tracker, making it the first and only FDA-cleared fertility tracking wearable.  A fertility tracking...

Bausch Health Companies Inc. ("Bausch Health" or the "Company"), Bausch + Lomb, a leading global eye health business, and Nicox (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that VYZULTA®...

Alfasigma Spa has finalized a licensing agreement to distribute Lumebluetm in the EU (plus Switzerland, UK, European Economic Area countries, Russia and...

Eisai Limited, the Canadian subsidiary of Eisai Inc., today announced the Canadian authorization and availability of a new non-sedative prescription medication, DAYVIGOtm (lemborexant).  Available in both 5 mg and 10 mg dosages, DAYVIGO is indicated...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the registration of the Russian Sputnik V vaccine against coronavirus by the Federal Commission for the Protection against Sanitary Risk of Mexico (COFEPRIS)....

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli...

Zenabis Global Inc.  ("Zenabis" or the "Company") announces today that its Maltese joint venture, ZenPharm Limited ("ZenPharm"), has received European Union Good Manufacturing Practices ("EU GMP") certification issued by the Malta Medicines...

FARAPULSE Inc. ("FARAPULSE" or "the Company") today announced that it has received the Conformité Européene (CE) Mark for its FARAPULSE Pulsed Field Ablation (PFA) system for the treatment of Paroxysmal Atrial Fibrillation (AF). The approval makes...

Vascepa included in Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology1  Chinese Society of Cardiology updated Guidelines now include Vascepa in its Prevention of Cardiovascular...

Nice-Pak, the pioneer and leading producer of wet wipes for consumer markets, announced that its surface disinfecting wipes (EPA Reg. No. 9480-5) sold under Nice `N CLEAN®, GRIME BOSS®, and private label brands received approval from the U.S....

In the recent years the use of CBD products have grown exponentially. They have become an everyday item in most people' lives. In drug and food stores, you see CBD infused items next to the candy section and infused 'gummy bears' in the vitamin...

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the European Commission (EC) has approved BAVENCIO® (avelumab) as monotherapy for the first-line maintenance...

The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today that the European Commission (EC) has granted a marketing authorization, for ELZONRIS (tagraxofusp) as monotherapy for the first-line treatment of...

Today, Bactiguard-coated Zimmer Biomet orthopaedic trauma implants received European regulatory clearance and CE mark. Preparations for registering the implants in the U.S. market are also ongoing. "I am very pleased that the CE mark has been secured...

The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today that the European Commission (EC) has granted a marketing authorization, for ELZONRIS (tagraxofusp) as monotherapy for the first-line treatment of...

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health"), today announced that LUMIFY® (brimonidine tartrate ophthalmic solution 0.025%) redness reliever eye drops have received approval from the Ministry...

Esaote North America announces that the MyLabtmX8 Ultrasound System has now been approved in Canada. Previously approved by FDA in...

ImmunoFlextm, a life sciences company developing clinically validated, pharmaceutical grade natural health products based on advancements in genomics research, today announced the approval of FLEX 10tm by Health Canada. "At ImmunoFlex, we work with...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the approval of the Russian Sputnik V vaccine against coronavirus by the Ministry of Health of the Republic of Paraguay....

Gracell Biotechnologies Inc. ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted approval for a pivotal seamless Phase...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia...

Incyte and MorphoSys AG today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab...

Lundbeck is pleased to announce that VYEPTI® (eptinezumab) has been approved by Health Canada for the preventive treatment of migraine in adults who have at least 4 migraine days per month....

Bristol Myers Squibb Canada (BMS) announced today that Health Canada has approved ONUREG® (azacitidine tablets) for use as the first and only maintenance therapy for adult patients with acute myeloid leukemia (AML) who achieved complete remission...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the registration of the Russian Sputnik V vaccine against coronavirus by State Agency for Medicines and Health Technologies (Agencia Estatal De Medicamentos Y...

KYE Pharmaceuticals Inc. ("KYE"), a private company headquartered in Mississauga, Ontario focused on bringing medicines that fulfill clinically significant unmet needs to the Canadian market, today announced an important milestone,...