News by subject: IMA

Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, announces that according to the information received from the Notified Body (Dekra), its European CE mark market authorization application for the RemeOstm trauma screw has returned...

- XPOVIO® is the first XPO1 inhibitor approved for reimbursement by South Korea's National Health Insurance Service (NHIS) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM). - The approval of XPOVIO® by the NHIS...

On June 25, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that Enlituo® (generic name: cetuximab beta injection), a new generation anti-epidermal growth factor receptor...

Biocon Biologics Ltd (BBL), a global, fully integrated biosimilars company and a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its...

Takeda Canada Inc. ("Takeda") is pleased to announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia® (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a...

GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced China's National Medical Products Administration (NMPA) has approved the clinical trial application for GFH375...

DeepQure, a Seoul based medical device company with a novel, extravascular (laparoscopic approach) solution for renal denervation (RDN), today announced initiation of its Early Feasibility Study (EFS) for the HyperQuretm system following FDA IDE...

Moon Surgical, a French-American pioneer in surgical innovation, announced today the United States Food and Drug Administration (FDA) clearance for the commercial version of its unique Maestro surgical system....

Kangpu Biopharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has recently approved a Phase II/III clinical trial of KPG-121 in combination with Abiraterone for a first-line treatment of metastatic castration resistant...

Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...

EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant progression-free survival (PFS) and overall survival (OS) benefits of sugemalimab in combination with chemotherapy as a first-line...

The high death rates in patients with cancer can be partly attributed to the increased risks of major adverse cardiovascular events (MACE). In a new study, scientists compared the incidences of MACE between patients with gastric cancer after...

SN Bioscience Co., Ltd. (CEO Park Young-hwan) announced on May 24 that European Medicines Agency(EMA) had granted an orphan drug designation for small cell lung cancer(SCLC), a rare disease, for SNB-101 (API: SN-38) which is a new polymer...

The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of risankizumab in adults with moderately to severely active ulcerative colitis (UC)1,2In both trials, the primary...

Calliditas Therapeutics AB ("Calliditas"), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation...

Teikoku Pharma USA (TPU) announced today that the NMPA (National Medical Products Administration) has approved Lidoderm® ("lidocaine 5% patch as lidocaine cataplasms") for the treatment of Post Herpetic Neuralgia (PHN) in China. TPU entered into an...

On the 24th of May, Kexing Biopharm (688136.SH) announced that Shenzhen Kexing Pharmaceutical Co., Ltd., its wholly-owned subsidiary, recently received a Notice of Approval for Drug Clinical Trials from the National Medical Products Administration,...

Full-Life Technologies (Full-Life), a fully integrated global radiotherapeutics company, today announced it has received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA) for clinical trials...

Global Group, Inc., in a strategic alliance with technology partner Oral Genome, is proud to announce an innovative program aimed at tackling global oral health disparities....

Bionoxx Inc., an innovative biotech company developing neutrophil-directed T cell modulation technology, announced today it will unveil its novel immunomodulatory technology at the upcoming 2024 BIO International Convention. Bionoxx research has...

Bionoxx Inc., an innovative biotech company developing neutrophil-directed T cell modulation technology, announced today it will unveil its novel immunomodulatory technology at the upcoming 2024 BIO International Convention. Bionoxx research has...

Sen-Jam Pharmaceutical, a leading innovator in the development of therapeutics for age-related diseases, is pleased to announce the upcoming completion of the clinical trial for its groundbreaking therapeutic, SJP-002C, in July 2024. SJP-002C targets...

Approval is based on the two largest Phase III trials conducted in HS ? SUNSHINE and SUNRISE ? demonstrating the safety and efficacy of Cosentyx® in HS1HS is a chronic, immunological, inflammatory skin condition estimated to affect 1 in 100 people...

Virtual-Ports Ltd is thrilled to announce the attainment of CE certification under the new MDR (Medical Device Regulation 2017/745) for its groundbreaking surgical products. Renowned for their single-hand, multi-application design, Virtual-Ports'...

PTC Therapeutics, Inc. announced today that the European Commission (EC) has decided not to adopt the CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarnatm (ataluren) and has...

Single Pass, Inc., the pioneer and sole provider of disposable electrocautery devices for preventing post-biopsy bleeding, is delighted to announce its strategic partnership with 3comma Medical / 3comma Medical GmbH, a commercial services firm that...

Sysmex, a leading diagnostic solutions company offering hematology, urinalysis, information systems and flow cytometry testing technology, has received a Medical Device License for the XF-1600tm Flow Cytometer, paving the way for a complete clinical...

Ractigen Therapeutics, a clinical-stage pharmaceutical company committed to developing pioneering therapies, today announces that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the...

Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced that the Center for Drug...

CathWorks announced today that the CathWorks FFRangio® System is now approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR, and fulfills the requirements for CE marking (0344). European Medical...

Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for the...

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...