News by subject: IMA

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...

Daewoong Pharmaceutical (CEO Sengho Jeon) announced on May 25 that the Indonesian joint venture Daewoong Infion (CEO Chang Woo Suh) obtained Halal certification for the diabetic foot ulcer drug 'Easyef topical...

Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received CE mark certification for the 14-Day version of the Carnation Ambulatory Monitor ("CAM")...

The Korean biotech company Macrogen (CEO Sukang Lee) (KOSDAQ: 038290), announced that it obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' from the Ministry of Food and Drug Safety (MFDS) on the 18th....