News by subject: IMA

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

Spinal Simplicity, a leader in innovative spinal solutions, is pleased to announce that its Minuteman® G5 interspinous fusion device has received regulatory clearance for commercial use in Australia and New Zealand. This milestone marks a significant...

Today, HYDRINITY Accelerated Skin Science, the fastest growing professional skincare brand in the US, is proud to announce their new partnership with Den Esthetics, a division of Den Medical of Belgium, a premier provider of the highest-quality...

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company's trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) was approved...

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer,...

Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase...

AbbVie today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients...

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma Industrial"), has received approval...

AI/ML health tech startup Respiree has received clearance from the Health Sciences Authority (HSA) to extend its RS001 cardio-respiratory wearable to pediatric populations. This clearance also enables the extension of Respiree's software platform,...

MediBeacon Inc. today announced the National Medical Products Administration (NMPA) in China has approved the MediBeacon® TGFR Monitor and TGFR Sensor for the assessment of kidney function in patients with normal or impaired renal function....

Kangpu Biopharmaceuticals, Ltd. ("Kangpu") today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of...

Telix Pharmaceuticals Limited today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by ALMPS[2] for the detection and...

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

Takeda (TSE: 4502) announced today that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with Hereditary Angioedema...

CathVision, a medical technology company developing advanced electrophysiology solutions, is proud to announce that it has received CE Mark for its breakthrough product, ECGenius System. This regulatory milestone allows CathVision to market and...

On February 17, VIVOZON Pharmaceutical announced that its non-opioid analgesic, UNAFRA Inj., was approved on December 12, 2024. (active ingredient: Opiranserin HCl), has received approval from the Ministry of Food and Drug Safety (MFDS). With this...

On February 17, VIVOZON Pharmaceutical announced that its non-opioid analgesic, UNAFRA Inj., was approved on December 12, 2024. (Active ingredient: Opiranserin HCl) has received approval from the Ministry of Food and Drug Safety (MFDS). With this...

Bioretec Ltd., a pioneer in absorbable orthopedic implants, has achieved a pivotal milestone with the successful completion of its CE mark approval process for the RemeOstm Trauma Screw product portfolio. With the CE mark, Bioretec can immediately...

IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that the Hong Kong Department of Health (DOH) has...

When a fatal car accident takes the life of a troubled teen, a devastated mother hopes that her child's donated organs will save the lives of others. She never imagines the impact her deceased daughter's DNA might have on the lives of the organ...

QuantalX Neuroscience Ltd. is proud to announce that its groundbreaking brain health assessment device, the Delphi-MD, has received CE MDR approval, the European Union's certification under the new Medical Device Regulation (MDR). The CE MDR...

A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.[1,2,3]...

Merck , known as MSD outside of the United States and Canada, announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a treatment for adult patients with resectable Stage II, IIIA, or IIIB...

Telix Pharmaceuticals Limited today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been approved by the Danish Medicines Agency (Lægemiddelstyrelsen). Illuccix,...

KeyMed Biosciences (HKEX: 02162) today announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New Drug Application (the "sNDA") of Stapokibart (anti-IL-4R? monoclonal antibody, trade name:...

Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EMA has accepted the MAA for BAT2506, a proposed biosimilar to Simponi®...

Accord Healthcare Limited (Accord) announced today that the anti-PD-1 mAb, serplulimab, marketed as Hetronifly® in Europe, has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly® in Europe), has been officially approved by the European Commission (EC) for use in combination with carboplatin and...

Astellas Pharma Inc. (TSE: 4503) (President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for Conditional Approval of avacincaptad pegol...

Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, today announced that the National...

HoneyNaps, a leader in AI-based sleep data analysis, announced on December 16 that its AI-powered sleep disorder diagnostic software, "SOMNUM", and its second-generation digital therapeutic for insomnia, "SOMNUM Medella," have been designated as...

AliveDx announces the receipt of IVDR-CE mark for its MosaiQ AiPlex® CTDplus multiplex assay. The multiplex assay enables a syndromic approach, simplifying laboratory workflow while delivering fast, actionable results to aid clinicians and...

Amgen today announced that the European Commission (EC) has approved BLINCYTO® (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell...

Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 today that their Marketing Authorization Application (MAA) for mavorixafor for the treatment of WHIM syndrome (warts, hypogammaglobulinemia,...

On January 22, 2025, Akeso Inc. (9926.HK) announced that it had received payment from Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. ("Sichuan Kelun") for their collaboration on the development of tagitanlimab, an innovative humanized...

Hugel Inc., a leading global medical aesthetics company chaired by Suk Cha, said on Wednesday it received approval for its botulinum toxin Botulax with aesthetic and therapeutic applications from the United Arab Emirates (UAE) on January 20,...

IMPACT Therapeutics ("IMPACT"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, is pleased to announce that Senaparib Capsules (???®?has received marketing...

Sen-Jam Pharmaceutical is excited to announce the preliminary results from its recently completed Phase 2 clinical trial evaluating the safety and efficacy of SJP-002C, a novel therapeutic for the treatment of Upper Respiratory Infections such as...

Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, today announced it has received Health Canada Licensing for the ECHO Green Pattern Laser photocoagulator. ECHO is the first and only portable, pattern...

ImmunoForge announced that it has received approval for the Phase 2 clinical trial IND for 'Pemziviptadil (development code name PF1804),' a treatment for DMD (Duchenne Muscular Dystrophy) cardiomyopathy, from the U.S. Food and Drug Administration...

Wound malodors are a quietly debilitating aspect of many patients' experiences. Along with personal discomfort, unpleasant smells from wounds can negatively affect social interactions. Cinesteam® is using innovative applications of cinnamon to make...

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

Genesis Medtech is proud to announce that iReach Omnia, the world's first powered stapler with 90° articulation capability, has been approved for market release in China by the National Medical Products Administration (NMPA). Independently developed...

Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New Drug Application (the "sNDA") of Stapokibart (anti-IL-4R? monoclonal antibody, trade...

A corporate plea is going out to the Church in America to gather together January 9-12th in Elkhart, IN, at the RV Hall of Fame. The body of Christ is uniting from all 50 states with one goal: to prepare for a nationwide call of repentance that leads...

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

When a troubled teenager has a fatal car accident, a young mother hopes that her child's donated organs will save others. She never imagines the impact her deceased daughter's DNA might have on the lives of multiple organ recipients....

Accord announces that the European Commission (EC has granted marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar to Stelara®, indicated for a range of immune medicated inflammatory diseases.The EC approval follows a...

Kidneyhood.org announces new results in The Evidence-Based Guide to Kidney and Renal Diets, a groundbreaking new book offering a new approach to managing kidney disease through diet. Kidneyhood.org's six book series has over 4,500 reviews on Amazon....

Recently, Porton Pharma Solutions Ltd. ("Porton") announced a strategic partnership with Aojin Life Sciences (Yixing) Co., Ltd. ("Aojin Life Sciences"). Porton will provide comprehensive CDMO services for Aojin in the CMC pharmaceutical research and...