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 cancer, metabolic, autoimmune and other major diseases announced...

WOMEN can now buy a contraceptive pill over the counter without a prescription following a consultation with a pharmacist after the UK's Medicines and Healthcare products Regulatory Agency (MHRA) today granted a licence to Maxwellia's Lovima®....

The San Marino Great and General Council approves Decree-Law no. 109 of 16 June, which puts in place its own green vaccination pass. This equips citizens, residents and others vaccinated in the territory with a certificate in line with the EU...

The San Marino Great and General Council approves Decree-Law no. 109 of 16 June, which puts in place its own green vaccination pass. This equips citizens, residents and others vaccinated in the territory with a certificate in line with the EU...

Dragonfly Biosciences Ltd ('Dragonfly') is pleased to announce Dragonfly CBD oil products are approved for use by the Australian Government's Therapeutic Goods Administration ('TGA'). The products have been approved under the TGA's Special Access...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) and Mexican pharmaceutical company Laboratorios de Biológicos y Reactivos de México (BIRMEX) announce the production of a test batch of the Russian Sputnik V vaccine against...

UL, the global safety science leader, has announced that its Performance Laboratory in Gavirate received World Health Organization (WHO) accreditation as a designated third-party testing laboratory for refrigeration...

LumiraDx announced today that it has achieved CE Marking for LumiraDx RNA STAR Complete SARS-CoV-2. The test, which was initially granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) in October of 2020 and...

Yiling Pharmaceutical disclosed in a statement on Monday that it had received the medicine registration document for Lianhua Qingwen Capsules from the Ministry of Health of Ukraine. As the leading product of Yiling Pharmaceutical, Lianhua Qingwen...

ZygoFix has obtained CE mark for its minimally invasive screwless spinal fusion system for the treatment of chronic back pain, the zLOCK Spinal Fusion System. ZygoFix completed the certification process and received CE mark for its zLOCK Spinal...

The TaurusElite® Transcatheter Aortic Valve Replacement System (hereinafter referred to as "TaurusElite®") developed by Peijia Medical (9996. HK) is approved for marketing by the National Medical Products Administration (NMPA) in June 2021 (Reg. No....

I-Mab (the "Company") , a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products...

Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor Libtayo now approved by the European Commission for three advanced cancers Regeneron...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the data of the Ministry of Health of the Buenos Aires province (Argentina), confirming the Russian Sputnik V vaccine against coronavirus has demonstrated the best...

On June 15, 2021, Jasper® SS?a new detachable coil independently developed by Achieva Medical, subsidiary of Peijia Medical (9996.HK)?was approved by the National Medical Products Administration ("NMPA") for commercialization (registration number...

Shenzhen Chipscreen Biosciences' licensing partner, HUYABIO International (HUYABIOtm), today announced the regulatory approval for Tucidinostat (also known as Chidamide, Epidaza ®, HBI-8000) monotherapy of relapsed or refractory (R/R) adult T-cell...

The first* CAR-T cell therapy approved by NMPA: opening a new era of cell therapy in China Individualized living-cell-based medicine: genetically modify patient's T-cells to expresses a chimeric antigen receptor (CAR) that will activate T-cells upon...

HUYABIO International (HUYABIOtm), the leader in accelerating global development of China's pharmaceutical innovations, today announced the regulatory approval for HBI-8000 monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma...

Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on developing first-in-class therapeutics for the treatment of cancer, rare conditions, and novel coronaviruses, today announced that it has submitted an...

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 and other major diseases announced...

QualiMed Innovative Medizinprodukte GmbH, a wholly owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3), announced that it has received CE mark approval for a dedicated percutaneous biodegradable metal alloy based stent implant...

- This is the first SARS-CoV-2 real-time RT-PCR test authorised for use in screening and testing asymptomatic and symptomatic individuals with results within 20 minutes, allowing health care professionals to take action quickly and confidently  - The...

Inovytec, a developer of medical devices that address emergency and routine respiratory and cardiac care, announced today that it signed a distribution agreement with Healthsoft to supply the United Arab Emirates (UAE) with hundreds of Inovytec's...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received a Pediatric...

Accuray Incorporated announced today the company has received CE Mark certification for its ClearRTtm helical fan-beam kVCT imaging capability. The Accuray-only ClearRT technology is now available to customers in the European Union, United States...

Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has issued an Interim Order authorization for casirivimab and imdevimab (REGN-COV2), to be administered together, for the treatment of mild to moderate coronavirus disease...

AbbVie , a research-based global biopharmaceutical company, today announced that Health...

Ascletis Pharma Inc. (HKEX: 1672) today announces that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its drug candidate ASC42 to conduct clinical trials for chronic hepatitis B...

PARIS, June 4, 2021 The European Medicines Agency has issued a favourable opinion on the marketing authorisation application for OZAWADEtm (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive...

1. VISEN Pharmaceuticals has obtained the investigational new drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the phase III China clinical trial (PaTHway China Trial) of...

miR Scientific, LLC, a healthcare company dedicated to transforming global cancer management by providing early and highly accurate detection, characterization and monitoring of disease, announced today that its Chairman & CEO, Sam Salman, will be...

MicuRx Pharmaceutical Co., Ltd. (MicuRx), a leading biopharmaceutical company focused on the discovery, development and commercialization of antibacterial agents against drug-resistant bacterial infection, announced that China National Medical...

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 and other major diseases, and Eli...

Kantaro Biosciences, LLC (Kantaro), a joint venture between the Mount Sinai Health System and RenalytixAI (LSE: RENS / NASDAQ: RNLX), and its commercial partner Bio-Techne Corporation , have received Health...

RIVANNA®, developers of world-first, imaging-based medical solutions, announced the European Patent Office has issued RIVANNA a notice of allowance for European patent application No. 13803513.4, entitled "Ultrasound Imaging of Specular Reflecting...

Occlutech AG ("Occlutech" or the "Company") today announces that the planned recruitment of 180 patients has been reached in the Company's trial in China for its ASD Occluder. The Occlutech ASD Occluder is used in the treatment of Atrial Septal...

AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to addressing critical unmet medical needs in ophthalmic, neurological and psychiatric disorders, today announced that China's National Medical Products...

Seelos Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has received European Orphan Drug Designation for SLS-005 in...

Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), fully dedicated to the R&D and commercialization of new drugs in the field of non-alcoholic steatohepatitis (NASH), today announces that China National Medical Products...

Medtronic plc , the global leader in medical technology, today announced CE (Conformité Européenne) Mark for expanded functionality of the company's InPentm smart2 insulin pen for multiple daily injections (MDI). The company also announced CE Mark...

Ibex Medical Analytics, the pioneer in AI-powered cancer diagnostics, today announced CE Mark for the Galentm Breast solution for use in supporting pathologists in detection of various types of breast cancer. The...

Vitacore Industries Inc. becomes the first Canadian company producing N95 respirators to receive European CE (FFP3) certification by the British Standards Institute for their CAN99, and recently became the first 99PFE-L3 respirator to be certified by...

AbbVie announced today that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia...

Ascletis Pharma Inc. (HKEX code: 1672) today announces that following the consultation with China National Medical Products Administration (NMPA), the clinical trial application of ASC40 combined with bevacizumab to treat patients with recurrent...

amg International GmbH ("amg" or the "Company"), a wholly owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3), further establishes its leadership role in the fast-paced development of novel biodegradable implants. The Company...

Prytime Medical Devices, Inc. announced today it has received both UK and CE Mark Approval for its next-generation ER-REBOA PLUStm Catheter. Designed for improved ease of use, this catheter replaces the market defining ER-REBOAtm catheter and...

BioMarin Pharmaceutical Inc. announced today that the European Medicines Agency (EMA) has granted its request for accelerated assessment of valoctocogene roxaparvovec, for adults with severe hemophilia A. Accelerated assessment reduces the time...

The FDA has greenlighted EndoFresh Disposable Digestive Endoscopy System, following years of reports of persistent cross-contamination issues being transmitted among multi-patients by the notoriously difficult-to-clean devices and efforts earlier...

CanSino Biologics Inc. ("CanSinoBIO") (SHSE: 688185, HKEX: 06185) today announced that its Recombinant Novel Coronavirus Vaccine, (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convideciatm), has been...

Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval of Klisyri®...