News by subject: IMA

LSNE Contract Manufacturing, a leading contract development and manufacturing organization, is pleased to announce that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of clinical stage biotechnology based...

Across the globe, there has been an increasing prevalence on brain cancer over the past few years and the industry is expected to grow as a result. The major driving factor responsible for the growth of brain tumors is the increasing prevalence of...

The health tech company Digital Diagnostics AG from Mainz, Germany, has received approval for clinical trials from a German ethics committee and the Federal Institute for Drugs and Medical Devices (BfArM). This is a crucial regulatory step in the...

Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) referred to as "Cipla" today announced that its partner Stempeutics Research Pvt. Ltd has received...

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health"), today announced that it has received approval from Australia's Therapeutic Goods Administration (TGA) for the supply of BAUSCH + LOMB ULTRA® ONE...

On August 11, 2020, the Ministry of Health of Uzbekistan released the Measures to Regulate the Circulation of Medicines, Medical Devices and Medical Facilities During the COVID-19 Pandemic, which approved those medicines in the white list to launch...

BioMarin Pharmaceutical Inc. announced today that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for vosoritide, an investigational, once daily injection analog of C-type Natriuretic Peptide...

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 and other major diseases, today...

An innovative, environmentally friendly treatment with no side effects has been made available to COVID-19 patients, involving the electrolysis of H2O to produce a mixture of hydrogen and oxygen for human inhalation. The results of the research as a...

Kaléo, a privately held U.S. pharmaceutical company, today announced that it has completed negotiations with the pan Canadian...

The Korean biotech company Macrogen (CEO Sukang Lee), announced on the 3rd that it had obtained the CE marking for Europe's In-Vitro Diagnostic (CE-IVD) devices for its coronavirus disease 2019 (COVID-19) test kit 'Axentm COVID-19 RT'. Europe's...

LimaCorporate announces that it is the first Italian company to obtain the EU Quality Management System certificate under the new European Medical Devices Regulation (MDR) from TÜV SÜD. In 2015, LimaCorporate formalized the development of a line of...

The European Commission (EC) has approved Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord)'s Zercepac®, a biosimilar trastuzumab, for the treatment of certain patients with HER2-positive early breast cancer,...

The European Commission (EC) has approved Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord)'s Zercepac®, a biosimilar trastuzumab, for the treatment of certain patients with HER2-positive early breast cancer,...

Gilead Sciences Canada, Inc. today announced that Health Canada has issued a marketing authorization with conditions (Notice of Compliance with Conditions, or NOC/c) for Veklury® (remdesivir). Under this conditional authorization, Veklury is...

VUNO Inc., South Korean artificial intelligence (AI) developer and a member company of the Born2Global Centre, announced that VUNO Med®-Fundus AItm, its AI-based screening solution for the fundus, gained the honor of being the first-ever Innovative...

Rapid Medical, a company focused on the development of next generation neurovascular devices, has announced that it received CE Mark for TIGERTRIEVER XL. In addition, the first patients have been treated successfully with the device.     The...

Insmed Incorporated , a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that SPRAVATO® (esketamine), following a Notice of Compliance (NOC) from Health Canada, is now available for Canadian patients. SPRAVATO® nasal spray, the first glutamate...

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

Angelini Pharma obtains exclusive development, manufacturing and commercialization rights to OV101 (gaboxadol) for the potential treatment of Angelman syndrome in the European Union and other countries in the European Economic Area (Switzerland,...

INSIGHTEC, a global medical technology innovator of incisionless surgery, announced today achievement of complete Medicare coverage across all 50 states for MR-guided focused ultrasound treatment of medication-refractory Essential Tremor. "INSIGHTEC...

SINOMED, a developer of innovative neuro- and cardiovascular technologies, announced the completion of the 1-year follow-up in the PIONEER-III, randomized global trial evaluating the BuMA Supreme Drug-Eluting Coronary Stent (DES). Once completed, the...

Sanofi Canada is pleased to announce that Health Canada has approved SARCLISAtm in combination with pomalidomide and...

LaunchPad Medical, Inc. announced that it has received approval from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to start a 15-patient pilot clinical study to examine the safety and efficacy of Tetranite®, the...

Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options for IDELVION® [albutrepenonacog...

Textile innovator HeiQ's antiviral textile technology, HeiQ Viroblock NPJ03, has been certified as safe and sustainable as all its ingredients are cosmetic grade, bio-based, and recycled....

Rakuten Medical, Inc. (Rakuten Medical) today announced that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has notified Rakuten Medical that its lead drug ASP-1929 will be reviewed under the Conditional Early Approval System (CEAS). ...

PTC Therapeutics, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended by a majority of votes to remove the statement "efficacy has not been demonstrated in...

Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that the Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally advanced, not metastatic...

Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that, on Jan. 30, 2020, EMA's CHMP expressed a favorable opinion to the request of a combination pack for the to-be-marketed pharmaceutical form of NidlegyTM, a...

In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, today announced the launch of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to...

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, today...

AceCann, a Portuguese medical cannabis company focused on the cultivation, processing, extraction and R&D of organic medical cannabis, has achieved a crucial milestone by receiving from Infarmed I.P. (Portuguese Health Authority) a pre-license for...

SciBase, a global healthcare company with a platform technology enabling innovative products for skin disorders such as skin cancer and atopic dermatitis, today announces that the company has submitted a reimbursement code application for its...

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that its facility in Suzhou has received European Medicines Agency (EMA) GMP certificate, following that from China National...

Aligned with its mission to improve and save lives with diagnostics, Ortho Clinical Diagnostics today announced Health Canada approval for its SARS-CoV-2 (COVID-19/coronavirus) Total antibody test?the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2...

The European Commission has today given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become available across Europe. This new vaccine builds on the well-established technology used in an existing adjuvanted trivalent...

OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. , today announced that it has received the CE mark certification in the European Union for its OPTI® SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus...

Halozyme Therapeutics, Inc. today announced that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX® (daratumumab), for the treatment of adult...

MedHub Ltd., a medical technology company focused on developing and commercializing AI powered medical solutions that aid in the diagnosis of cardiac disease, announced that is has gained AMAR approval for its AutocathFFR system. AutocathFFR is an...

Mylan N.V.  and Lupin Limited (Lupin) today announced that the European Commission (EC) has granted marketing authorization for Nepexto®, a biosimilar to Enbrel® (etanercept), for all indications of the reference product including rheumatoid...

SightGlass Vision, Inc., a life sciences company focused on ending nearsightedness (myopia), today announced it has achieved Conformité Européene (CE) Mark declaration on its first product ? the Company's novel eyeglasses designed to slow the...

ReddyPort, a medical technology company focused on solutions that enable better care experiences for patients on non-invasive ventilation (NIV), announced today that it has received Conformité Européene (CE) Mark approval for ReddyPorttm Elbow. The...

Lunit today announced that its AI solution for breast cancer, Lunit INSIGHT MMG, has been CE certified. The medical software was certified on May 26th, making it now commercially available across the European Economic Area. The certified...

Longeveron LLC announced today that Japan's Pharmaceutical and Medical Devices Agency (PMDA) (the Japanese agency akin to the United States' Food & Drug Administration) approved a Clinical Trial Notification (CTN) application (akin to an...

Akcea Therapeutics, Inc. , a majority-owned affiliate of Ionis Pharmaceuticals, Inc., today announced the Portuguese Medicine Regulatory Authority (INFARMED) has granted approval for reimbursement of TEGSEDI® (inotersen) for the treatment of stage 1...

Akcea Therapeutics, Inc. , a majority-owned affiliate of Ionis Pharmaceuticals, Inc., today announced the Portuguese Medicine Regulatory Authority (INFARMED) has granted approval for reimbursement of TEGSEDI® (inotersen) for the treatment of stage 1...

Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending...

MYR Pharmaceuticals 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 a conditional marketing authorization (CMA) for the...