News by subject: IMA

Brand Institute, the global leader in pharmaceutical and healthcare related name development, is proud to announce its role in naming Pfizer and BioNTech's COVID-19 vaccine: COMIRNATY® (koe mir' na tee). The name was first announced by Swiss...

Vertex Pharmaceuticals Incorporated  today announced its New Drug Submission for TRIKAFTA®, Vertex's investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the registration of the Russian Sputnik V vaccine against coronavirus by The National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT)....

Halozyme Therapeutics, Inc. today announced that the European Commission has approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with Halozyme's ENHANZE® technology, administered by subcutaneous...

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, today...

Medtronic Canada ULC, a subsidiary of Medtronic plc announced today that it has received a Health Canada licence for Micratm AV, the world's smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients...

Garching - OncoBeta® GmbH and their subsidiary OncoBeta Therapeutics Pty Ltd. Australia a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanoma Skin Cancers (NMSCs), announced today that the Rhenium-SCT...

Yiling Pharmaceutical discloses on Wednesday that it has received the Approval of Registration approved and issued by the Medicines Control Authority of Zimbabwe, which indicates that the Company's patented product of "Lianhua Qingwen Capsules" meets...

Medtronic Canada ULC, a subsidiary of Medtronic plc ? the world's largest medical technology, services, and solutions company ? has received a licence from Health Canada for its MiniMedtm 770G insulin pump system. This is currently the only insulin...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the adalimumab biosimilar HLX03, developed and manufactured by the Company independently, has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the adalimumab biosimilar HLX03, developed and manufactured by the Company independently, has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid...

Acuva Technologies Inc. ("Acuva"), today announced successful validation of the Acuvatm SOLARIS handheld disinfecting wand against SARS-CoV-2 (COVID-19). The test report confirms that a >99.97% level of disinfection was achieved in 10 seconds....

Regent Pacific Group Limited ("Regent Pacific" or the "Company" and together with its subsidiaries, the "Group"; stock code: 0575.HK), a specialist healthcare, wellness and life sciences investment group is pleased to announce that Wanbang...

European based company Selfdiagnostics (GER, EST) plans to submit request for authorisation of its molecular diagnostic test for home and for point of care use ? to detect the coronavirus SARS-CoV-2. Selfdiagnostics rapid PCR is first multifunctional...

Diabeloop announced today that it has obtained CE marking for its innovative and adjustable technological solution: DBL-hu.DBL-hu improves glycemic control and satisfaction for people living with a form of diabetes that is very complex to...

Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for DESCOVY® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for Pre-Exposure Prophylaxis (PrEP) to reduce the...

Rapid Medical, a company focused on the development of next-generation neurovascular devices, has announced CE Mark approval for the expanded indication of Comaneci to treat cerebral vasospasm. Comaneci is the first adjustable remodeling mesh device...

Rapid Medical, a company focused on the development of next-generation neurovascular devices, has announced CE Mark approval for the expanded indication of Comaneci to treat cerebral vasospasm. Comaneci is the first adjustable remodeling mesh device...

Health Canada today granted authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12...

Aruvant, a clinical-stage biopharmaceutical company focused on developing and commercializing transformative gene therapies for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted orphan designation...

AbbVie , a global, research and development-based biopharmaceutical company announced today that Health Canada has approved a label change for MAVIRET®...

Precision Biomonitoring announced today it has received Health Canada approval for its ready-to-use thermostable SARS-CoV-2 TRIPLELOCKtm Test Strips for use across Canada. The TRIPLELOCKtm Test Strips are a rapid, point-of-need diagnostic...

The Valens Company Inc. (the "Company" or "The Valens Company"), a global leader in the end-to-end development and manufacturing of innovative, cannabinoid-based products, today announced that the Victoria State Government in Australia has granted...

Global biotherapeutics leader CSL Behring announced today that its investigational, plasma-derived hemopexin therapy (CSL889) received orphan drug designation from both the European Commission and the U.S. Food and Drug Administration (FDA) Office of...

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its new VITROS® SARS-CoV-2...

Medtronic Canada ULC, a subsidiary of Medtronic plc ? the world's largest medical technology, services, and solutions companies ? announced today that it has received a Health Canada licence for the Percepttm PC Deep Brain Stimulation (DBS) system...

Medasense Biometrics Ltd. announced today that its NOL® pain response monitoring device (PMD-200tm) has been approved for marketing in Brazil by ANVISA, the Brazilian health regulatory agency. Medasense's NOL technology enables clinicians to optimize...

Insmed Incorporated , a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the European Commission (EC) has granted marketing...

The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund), has submitted applications to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of the world's first...

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its new VITROS® SARS-CoV-2 Antigen test, designed to detect active SARS-CoV-2 infection, achieved CE Mark for distribution throughout the EU. The company also...

Incyte today announced that Health Canada has accepted its New Drug Submission (NDS) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for adults with previously treated, unresectable, locally advanced...

Kantaro Biosciences, LLC (Kantaro), a joint venture between the Mount Sinai Health System and RenalytixAI (LSE:RENX / NASDAQ: RNLX), and...

CollPlant a regenerative and aesthetic medicine company, today announced that it has received a substantial first order totaling hundreds of thousands of U.S. dollars for its Vergenixtm Flowable Gel (FG) product in Ukraine from CollPlant's new...

Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced that the European Commission has granted orphan drug designation for leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS),...

Isla Pharmaceuticals, a US-based company focused on rational repurposing of molecules for the treatment or prevention of viruses is pleased to announce that a key patent relating to the Company's lead program, Isla101 has been granted by the...

COVID-19 has fundamentally changed the world, but it has also undeniably led to an acceleration of driving new progressive technology. For instance, Cloud computing, AI and Automation is making existing processes ? in response to more strained global...

Akero Therapeutics, Inc. , a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that the European...

Micro Medical Solutions (MMS) today announced CE Mark approval for the 2.5 mm MicroStent vascular stent, the smallest diameter MicroStent to date. Also granted CE Mark approval is the long (120 cm) over-the-wire balloon catheter, MicroBalloon XL. The...

Almirall, S.A. (ALM) announced today that it has signed an agreement with the French Authorities to make the biologic treatment ILUMETRI® (tildrakizumab), a high-affinity IL-23p19 monoclonal antibody, available in France for the treatment of adult...

Almirall, S.A. (ALM) announced today that it has signed an agreement with the French Authorities to make the biologic treatment ILUMETRI® (tildrakizumab), a high-affinity IL-23p19 monoclonal antibody, available in France for the treatment of adult...

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...

Bristol Myers Squibb announced today that Health Canada approved ZEPOSIA® (ozanimod) for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.i...

The manufacturing arm of Green Roads, Clarity Labs LLC, has received the permit to be an official Over the Counter products manufacturer from the Florida Department of Business and Regulation. OTC certification is extremely rare among CBD brands,...

PixCell Medical, innovator of rapid diagnostic solutions at the point-of-care, announced today that it has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for the HemoScreentm, PixCell's hematology analyzer...

Allergan Inc., an AbbVie Company, is working closely with Health Canada to voluntarily withdraw FIBRISTAL® (ulipristal acetate tablets, 5 mg) across Canada.  Allergan has reviewed the benefits and risks for FIBRISTAL® following reports of rare cases...

Medimetriks Pharmaceuticals, Inc. today announced that Otsuka Pharmaceuticals Co. Ltd., submitted an application for approval of MM36 (difamilast) to the Japanese regulatory authorities.  Positive MM36 results in two Phase 3 Japanese clinical trials...

Guide Sensmart ("the Company"), a world leading manufacturer of infrared thermal imaging systems, has had its IR236 IR Fever Warning System added to the list of authorized medical devices for uses related to COVID-19 by Health Canada. The authorized...

Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. announced today that Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with...

Rakuten Medical Inc. is proud to announce that its wholly owned subsidiary Rakuten Medical Japan K.K. has received marketing approval in Japan from the Ministry of Health, Labour and Welfare for Akalux® IV Infusion 250mg (cetuximab saratolacan...

Takeda UK Ltd. is pleased to announce that following a review meeting in July 2020, the NHS England Clinical Priorities Advisory Group (CPAG) has provided a positive recommendation for the routine commissioning of VEYVONDI®?(vonicog alfa), the first...