News by subject: IMA

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...

Single Pass, a leading provider of innovative medical devices, is pleased to announce an exclusive distribution agreement with Mermaid Medical Group, a renowned global medical technology company. This partnership will bring Single Pass's cutting-edge...

Halozyme Therapeutics, Inc. ("Halozyme") today announced that argenx received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection co-formulated with Halozyme's...

AIRS Medical, a leading AI-powered healthcare solution provider, is thrilled to announce that it has received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution 'SwiftMRtm'. This certification allows AIRS...

Pulsenmore , the global leader in self-scan ultrasound technology for home use, proudly announces the approval of its pioneering prenatal care solution by the Brazilian Health Regulatory Agency (ANVISA), marking a significant milestone in the...

Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for autoimmune diseases and pain, has announced today that China National Medical Products Administration (NMPA)...

AbbVie today...

Medtronic plc , a global leader in healthcare technology, today announced CE (Conformité Européenne) Mark approval for the MiniMedtm 780G system with Simplera Synctm, a disposable, all-in-one continuous glucose monitor (CGM) requiring no fingersticks...

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...

Rehabtronics Inc announces it has successfully upgraded its ISO13485:2016 quality certification to include the internationally-recognized Medical Device Single Audit Program (MDSAP) standard. The additional certification confirms the company's...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that its New Drug Application (NDA) for...

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that Taiwan Food and Drug Administration has approved its Phase II IND...

Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer,...

Northwest Biotherapeutics ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that a Marketing Authorization Application (MAA) was submitted yesterday to the Medicines and...

NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd., announced that, on December 13, 2023, the European Commission (EC) has granted orphan drug designation for NS-089/NCNP-02, which is being developed for the treatment of Duchenne...

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,...

Inovedis GmbH, a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions, today announced that the first two patients were...

Blueprint Medicines Corporation? today announced the European Commission has approved AYVAKYT® (avapritinib) for...

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for...

The marketing authorisation (MA) for Eluciremtm (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the "A Randomized, Open-label,...

Novavax, Inc. , a global company advancing protein-based vaccines with its Matrix-Mtm adjuvant, today announced that Health Canada has granted expanded authorization for Nuvaxovidtm XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for...

Mission Therapeutics ("Mission" or the "Company"), a clinical-stage biotech developing first-in-class therapeutics targeting...

23 Nov, 2023, on the second anniversary of the initial approval for olverembatinib, Ascentage Pharma hosted a ceremony in Suzhou, China, marking the launch of olverembatinib in a newly approved indication and the dispatch of the first batch of the...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that China's National Medical Products...

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...

EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission...

Huma's platform is ready to use, reducing the time and cost for other companies to bring regulated SaMD products to market, democratising digital health innovation across the industryClass C certification expands the patient population and level of...

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that U.S. Food and Drug Administration has approved its Phase II IND...

Takeda (TSE:4502/NYSE:TAK) today announced the European Commission has approved TAKHZYRO® (lanadelumab) for the routine prevention of recurrent attacks of...

Johnson & Johnson MedTech* today announced that the MONARCH Platform and MONARCH Bronchoscope have obtained regulatory approval in China. The platform is the first minimally invasive, robotic-assisted technology approved for peripheral lung...

ARUP Laboratories today announced that it has gained the Conformité Européenne (CE) mark for AAV5 DetectCDxtm single-site use under the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR). AAV5 DetectCDxtm is a companion diagnostic...

CASI Pharmaceuticals Inc. , a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, is thrilled to announce a major milestone in its partnership with Juventas Cell Therapy Ltd....

Executives of many multinational companies have expressed their confidence in the Chinese market and vowed to further expand their businesses in the country, as they explore opportunities at the ongoing China International Import Expo (CIIE) in...

Lilly Canada is pleased to announce that Mounjaro®...

Gedeon Richter Plc. ('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland, GmbH ('SMPS') today announce that the European Commission ('EC') has granted approval of a Type II Variation application for RYEQO®...

Ultomiris (ravulizumab) has been approved by Health Canada as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder...

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,...

Syqe Medical, a global leader in innovative medical inhalation technology, together with Australian sponsor and distribution partner Novachem, is pleased to announce a significant milestone in its mission to improve the lives of patients worldwide....

Novavax, Inc. , a global company advancing protein-based vaccines with its Matrix-Mtm adjuvant, today announced the...

AIRS Medical...

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

Aidoc today announced a pioneering collaboration with the Pulmonary Embolism Response Team (PERT) at UZ Brussel (UZB), becoming the first European hospital to use AI for cross-departmental care coordination, expediting treatment for suspected...

Merck , known as MSD outside the United States and Canada, and Eisai announced today that KEYTRUDA®, an anti-PD-1 therapy, in combination with LENVIMA®, the multiple receptor tyrosine kinase inhibitor discovered by Eisai, is reimbursed under the...