News by subject: IMA

The Perinatal Stem Cell Society has organized a workshop Nov. 3 in Fort Lauderdale, Fla. and streamed to unite the biologics industry and work with the FDA towards a patient-centered goal. "I called this one-day workshop so the industry can partner...

Accuray Incorporated announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved reimbursement for the CyberKnife® System for the treatment of trigeminal neuralgia (TN). The system provides an important new option for...

Single Pass, Inc. CEO, Bill Colone, announced treatment of the first patients in North America with the Kronos Electrocautery device designed to improve the safety of co-axial biopsy procedures. The single-use, disposable device uses battery current...

Medtronic plc , a global healthcare technology leader, has announced three significant global market-entrance and indication expansion approvals for its Hugotm robotic-assisted surgery (RAS) system. The approvals include: Conformité...

TAICEND TECHNOLOGY intends to target its marketing strategy primarily on the US medical market. We will participate in the MedTrade East International Medical Home Care and Rehabilitation Exhibition for the first time on October 24-26 this year. It...

SQI Diagnostics Inc. , a leader in the science of lung health that develops and manufactures respiratory health...

Akeso, Inc. (9926. HK) ("Akeso"), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, announced the Phase Ib/II clinical trial of its in-house...

Telix Pharmaceuticals Limited  today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved an investigational new drug (IND) application to commence a pivotal Phase III registration...

Atara Biotherapeutics, Inc.  and Pierre Fabre today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion...

Telix Pharmaceuticals Limited  announces that Health Canada has approved Illuccix® [kit for the preparation of gallium (68Ga) gozetotide injection] for use in staging and re-staging intermediate and high-risk prostate cancer and localizing tumour...

According to International Diabetes Federation, approximately 537 million adults (20-79 years) are living with diabetes worldwide and 206 million adults of the Western Pacific region including China, Japan, and South Korea have diabetes in 2021....

According to International Diabetes Federation, approximately 537 million adults (20-79 years) are living with diabetes worldwide and 206 million adults of the Western Pacific region including China, Japan, and South Korea have diabetes in 2021....

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...