News by subject: IMA

Biosense Webster, Inc., part of Johnson & Johnson MedTech?, today announced the European launch of the HELIOSTARtm Balloon Ablation Catheter ? the first radiofrequency balloon ablation catheter. The HELIOSTARtm Balloon Ablation Catheter is indicated...

On May 10, 2022, Vitacore Industries Inc. received approval for its CAN99 9500 respirator from the National Institute for Occupational Safety and Health (NIOSH). NIOSH is part of the Centers for Disease Control and Prevention (CDC) in the United...

IceCure Medical Ltd. ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by...

IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative medicines and Cabaletta Bio, Inc. , a clinical-stage biotechnology company focused on developing and...

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that it has submitted a Marketing Authorisation Application (MAA)...

JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has...

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, ophthalmology and other major...

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, ophthalmology and other major...

Gestalt Diagnostics, Inc., a leading provider of award-winning digital pathology solutions, announced today that it has received CE-IVD marks for two of the main components of PathFlow. Both the PathFlow viewer and the proprietary, automated...

Everest Medicines Limited (HKEX 1952.HK, "Everest Medicines", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in...

COMIRNATY Original & Omicron BA.4/BA.5 now authorized in Canada as a booster dose for individuals 12 years of age and olderAuthorization is based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines as well as data...

BioVaxys Technology Corp. (FRA: 5LB)  ("BioVaxys" or "Company") announced today that it has executed a binding Term Sheet ("Term Sheet" or "Agreement") with Procare Health Iberia, S.L. ("Procare Health"), of Barcelona, Spain ("Procare Health"), for...

BioVaxys Technology Corp. (FRA: 5LB)  ("BioVaxys" or "Company") announced today that it has executed a binding Term Sheet ("Term Sheet" or "Agreement") with Procare Health Iberia, S.L. ("Procare Health"), of Barcelona, Spain ("Procare Health"), for...

Oncopeptides AB (publ) , a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Company has submitted the AMNOG dossier to "The Federal Joint Committee" (G-BA) in...

Each year more than 1,300 people in Canada are diagnosed with cervical cancer and more than 400 die. It doesn't have to be this way. Cervical cancer is nearly always caused by the human papillomavirus (HPV), a common sexually transmitted infection...

BioVaxys Technology Corp. (FRA: 5LB)  ("BioVaxys" or "Company") announced today that in an action that further expands the value of their IP portfolio, the Company has broadened the patent coverage for its viral vaccine platform by filing an...

Telix Pharmaceuticals Limited  today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a pivotal Phase III registration study that will bridge to Telix's global Phase III 'ZIRCON'...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that an initial one million doses of Nuvaxovidtm (NVX-CoV2373) COVID-19 vaccine are now...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received...

-  CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one for maintenance1,2-  Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing...

ATMA Journey Centers Inc. ("ATMA"), an Alberta-based company focused on the international delivery of innovative psychedelic-assisted therapy solutions, announced today that it has received approval from Health Canada to move forward with its N500...

AnBogen Therapeutics, a clinical-stage biotech company designing and developing precision oncology therapies to improve the life of patients, announces today that U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND)...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today...

Merck , known as MSD outside the United States and Canada, announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has approved the expanded conditional marketing...

YishengBio Co., Ltd., ("YishengBio"), a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics, announced that the Company received the approvals...

Verseon is pleased to announce that the European Patent Office has granted intellectual property protection covering novel chemical matter developed by Verseon that includes the company's plasma kallikrein inhibitors (PKIs). These compounds could...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has expanded its temporary...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Nuvaxovidtm (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded...

LASEROPTEK Co., Ltd., a developer, and manufacturer of world-class laser devices for aesthetic and medical dermatology applications, is pleased to announce its HELIOS IV-785 laser system recently received...

Devyser has today been certified under the new, more comprehensive IVD Regulation that came into force on May 26, 2022. The certification, issued by the notified body TÜV SÜD, covers Devyser's quality management system and fetal diagnostics product....

IceCure Medical Ltd. ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has submitted a...

Lunit (KRX: 328130.KQ), a leading medical AI provider, today announced that it received commercial approval in Taiwan for Lunit INSIGHT MMG, the company's AI solution for mammography analysis. Recently, the Taiwan Food and Drug Administration...

UltraSight, an Israeli-based digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced it has obtained a CE Mark for its AI guidance software for cardiac ultrasound. Today's milestone comes just ahead...

BioLife Solutions, Inc.  ("BioLife" or the "Company"), a leading developer and supplier of class-defining bioproduction products and services for the cell and gene therapies ("CGT") and the broader biopharma markets, today announced the appointment...

BioMarin Pharmaceutical Inc. today announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to ROCTAVIANtm...

Thorne HealthTech, Inc. ("Thorne HealthTech" or "Thorne") , a leader in developing innovative solutions for a personalized approach to health and wellness and majority owner of Drawbridge Health announced today that its OneDrawtm Blood Collection...

CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Turkish Ministry of...

-- Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA -- Ascletis has filed multiple patent applications for ASC10 and its use globally. Compared with...

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, announced today that the Center for Drug Evaluation (CDE) of China's...

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted expanded provisional approval for Nuvaxovidtm...

CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, was recently granted a CE Mark certificate for two of the company's monkeypox diagnostic tests. The CE Mark, granted on May 23, 2022,...

Edwards Lifesciences Corporation , today announced the company's PASCAL Precision transcatheter valve repair system received CE Mark for the treatment of mitral and tricuspid regurgitation (MR and TR)....

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted expanded provisional approval...

CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Israeli Ministry of...

Otsuka Canada Pharmaceutical Inc. (OCPI) today announced that Health Canada has approved KORSUVA (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing...

Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced today the expansion of its partnership with Albireo to a multi-regional agreement to...