News by subject: IMA

Golden Helix, Inc., a leading provider of clinical bioinformatics solutions, is pleased to announce that it has received CE mark approval for its genetic analysis platform VarSeq Suite. This significant regulatory milestone paves the way for the...

Anaut Inc., a pioneering developer in surgical support software led by CEO Dr. Nao Kobayashi, announced regulatory approval of its groundbreaking medical device, "Eureka ?". This first-of-its-kind software device in Japan received approval from the...

Stratus® Medical, a company focused on improving clinical outcomes for chronic pain patients by advancing radiofrequency (RF) technology for the treatment of pain, announced today the expansion of patent protection in Europe for its NIMBUS®...

In a significant stride towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces the attainment of EU-MDR (European Medical Device Regulation)1 certification for their VIRUS vs. BACTERIA Clinical Decision Support...

In a significant stride towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces the attainment of EU-MDR (European Medical Device Regulation)1 certification for their VIRUS vs. BACTERIA Clinical Decision Support...

Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of OBGEMSAtm (vibegron under the international...

Astellas Pharma Inc....

Front Line Medical Technologies Inc, a leader in innovative medical devices for emergency and trauma care, today announced that its innovative COBRA-OS® (Control Of Bleeding, Resuscitation, Arterial Occlusion System) has officially been granted CE...

Subcutaneous (SC) injection offers an alternative administration option to intravenous (IV) infusion, with the opportunity to provide greater flexibility and convenience for patients, healthcare providers, and healthcare systems in how cancer...

South Korea's biotechnology company Hyundai Bioscience (CEO Oh Sang-gi, www.hyundaibioscience.com) announced on April 15 that it would carry out global clinical tests aimed at treating all serotypes of Dengue virus infection....

Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based...

Norgine B.V. today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This...

16 Bit Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo marketing authorization for Rhotm, an AI-enabled software device aimed at improving a known care gap in osteoporosis screening. Rho received...

Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Denosumab Injection (trade name: MAIWEIJIAN, R&D code: 9MW0321) developed by its wholly-owned subsidiary T-mab has officially obtained the...

Asep Medical Holdings Inc. ("Asep" or the "Company") is very pleased to announce that its joint venture company with leading Chinese biotech company Sansure Biotech Inc. ("Sansure"), Hunan Sanway SepSMART Ltd. ("SepSMART"), which is based in...

Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China and the United States, today announced it has been granted a new Class III certificate by the National...

IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the...

Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, our PSMA -11 kit, has received marketing authorization in the Netherlands (RVG 130527). This landmark approval marks a significant milestone in our ongoing commitment to...

Norgine B.V. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment...

Innodem Neurosciences, a leading digital health and AI company, announced today that its ETNAtm-MS has been cleared for commercial use by Health Canada.  The Eye Tracking Neurological Assessment for Multiple Sclerosis (ETNAtm-MS) is a software as a...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Singapore Health...

CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not...

Inspiratm Technologies OXY B.H.N. Ltd. (the "Company" or "Inspira"), a breakthrough medical technology company, is excited to announce the AMAR submission for approval of the INSPIRAtm ART100, marking a significant milestone in Inspira's venture...

Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue, is pleased to announce the approval in Brazil of STIMULAN as a calcium...

Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue, is pleased to announce the approval in Brazil of STIMULAN as a calcium...

X-Nav Technologies, LLC announced that the X-Guide® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017/745, commonly referred to as EU MDR....

Rippon Ubhi, Country Lead, Sanofi UK and Ireland, said: "We are extremely disappointed and saddened by the decision by the National Institute for Health and Care Excellence (NICE) not to recommend Xenpozyme (olipudase alfa) as a treatment for acid...

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

YolTech Therapeutics, a biotech company developing in vivo gene editing therapies to treat rare genetic diseases, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially  approved the...

Insightec, a pioneer and global leader in focused ultrasound, is pleased to announce that its transcranial MR-guided focused ultrasound (MRgFUS) has been granted NUB status 1 for the treatment of essential tremor (ET) in Germany. This significant...

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that today the National Medical Products Administration...

Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S....

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson...

As previously announced, planning is underway with FDA to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI)As anticipated, an End of Phase 2 Meeting (EOP2) with FDA is now confirmed to occur...

Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) approved Kezar's investigational new drug (IND) application for...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s partner Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age...

Zylox-Tonbridge (2190.HK), a medical device company specializing in peripheral and neurovascular interventions, proudly announces the recent marketing approvals granted by the Ministry of Health and Prevention in the United Arab Emirates for five of...

Merck , known as MSD outside the United States and Canada, announced that Health Canada has granted approval of  KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing...

CSOFT Health Sciences, leaders in clinical trial translation, are pleased to announce the launch of their co-authored white paper for medical device manufacturers seeking re-certification under the updated EU Medical Device Regulation (EU MDR), in...

Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for autoimmune diseases and pain management, is pleased to announce the approval of the Investigational New Drug...

In the news release issued 19-Sep-2023 by Deep Bio over PR Newswire, we are advised by the company that in the initial release, it was inaccurately stated in the headline, first and second paragraphs that Deep Bio obtained marketing authorization...

Insightec, a pioneer and global leader in focused ultrasound, has welcomed a positive recommendation report[1] from the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) to have MR-guided focused ultrasound (MRgFUS) reimbursed for people...

Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received 'Orphan Drug...

Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received 'Orphan Drug...

Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the...

PTC Therapeutics, Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion following the re-examination procedure for the conditional marketing authorization...

Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada has issued a Notice of Compliance for REXULTI® (brexpiprazole) for use in the symptomatic management of agitation associated with Alzheimer's...

Anixa Biosciences, Inc. ("Anixa" or the "Company") , a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that its collaborator, Cleveland Clinic, has received a "Decision to Grant" notice from the...

GC Biopharma Corp. (006280.KS) announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its intracerebroventricular (ICV) Enzyme Replacement Therapy (ERT) candidate, GC1130A, designed for Sanfilippo Syndrome...

NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd, announced today that the European Commission (EC) has granted orphan drug designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic...