News by subject: IMA

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the approval of the Russian Sputnik V vaccine against coronavirus in the Republic of Indonesia....

PTC Therapeutics, Inc.  today announced that the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved Waylivratm (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS) in...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) today announced the Russian single-component Sputnik Light vaccine against coronavirus has been approved under the emergency use authorization procedure by the Food and Drug...

AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on rare, childhood-onset neurogenetic disorders with limited or no treatment options, today announced that the Company has received innovative licensing and access...

Galmed Pharmaceuticals Ltd. ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the Medicines and Healthcare products Regulatory Agency (MHRA), the...

Nasus Pharma, a privately held clinical-stage biopharmaceutical company developing a powder-based intranasal (PBI) therapeutic solutions today announced  that the Spanish Medicines and Medical Devices Agency(AEMPS) allowed Taffix to be...

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and coronaviruses, today announced that its novel oral drug, Silmitasertib, has been included in Taiwan's Center for...

Merck , known as MSD outside the United States and Canada, today announced the initiation of a rolling submission to Health Canada for molnupiravir, an investigational twice daily oral antiviral agent currently in trials as a potential treatment for...

Protector Ray 10, a new disinfection device for category 2 medical equipment such as wheelchairs, walkers and orthopedic devices, developed by Lanaudière entrepreneur Pierre Félix Brisson, received Health Canada approval. The Protector Ray 10 is the...

GW Pharmaceuticals ("GW"), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines and now part of Jazz Pharmaceuticals plc , today announces that the UK Medicines and Healthcare Products Regulatory...

GW Pharmaceuticals ("GW"), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines and now...

ImmVira announced that as a global first, its lead oncolytic virus therapy program MVR-T3011 IV (also known as T3011), obtained approval from National Medical Products Administration ("NMPA") for clinical trial for treatments using intravenous...

Akeso, Inc. (9926.HK, the "Company" or "Akeso") announced that the anti PD-1 monoclonal antibody drug Penpulimab monoclonal antibody injection co-developed by the Company with Sino Biopharmaceutical Limited (stock code: 1177.HK), has obtained...

Filament Health Corp. (NEO: FH) ("Filament" or the "Company"), a leading exclusively-natural psychedelic drug development company, today announced that it is the first public company to be issued a patent by the Canadian Intellectual Property Office...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the initial safety results of the randomized, single-blind study for the evaluation of the immune response and safety of heterogeneous regimens combining the first...

Immunovia AB (publ) ("Immunovia"), a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, today announced that Immunovia, Inc. has received final approval to begin patient testing for...

Singapore-based AI company TAIGER announced today the veteran technology executive, Stephen Watts, has joined the company as its Chief Operating Officer.  Watts brings to TAIGER extensive global leadership in software and services.  He...

Filament Health Corp. (NEO: FH) ("Filament" or the "Company"), a leading exclusively-natural psychedelic drug development company, today announced that it is the first public company to be issued a patent by the Canadian Intellectual Property Office...

The nation's largest pure-play distributor of scientific products, Thomas Scientific, has successfully completed ISO 9001:2015 Certification for all seven of its United States facilities as of July 28th, 2021. The certification affirms Thomas...

Accelerate Diagnostics, Inc. today announced that the new IVD configuration of its Accelerate PhenoTest® BC kit has been CE marked and is ready for use in Europe....

GSK today announced it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for PRIORIX (Measles, Mumps, and Rubella Virus Vaccine, Live) and is seeking approval for use in active immunization against...

Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the...

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology,...

BrainStorm Cell Therapeutics Inc. , a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three...

Nurosene Health Inc. ("Nurosene" or the "Company") , a health-tech company focused on building a generation of better brains, is pleased to announce approval from Health Canada to sell Nuro Drive ("Drive") and Nuro Restore ("Restore"), its...

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has received the License of Manufacturing Permit from German health authorities...

Rational Vaccines, a company focused on revolutionizing the treatment of herpes to eradicate the disease, today announced that it has been awarded an Innovation Passport under a new process in the United Kingdom (UK) to bring innovative medicines...

Ascletis Pharma Inc. (HKEX code: 1672) today announces that China National Medical Products Administration (NMPA) has approved the Phase III clinical trial application of ASC40 combined with Bevacizumab for treatment of patients with recurrent...

Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults....

Klisyri® (tirbanibulin) is a topical microtubule inhibitor indicated for the treatment of actinic keratosis (AK) of the face or scalp in adults and it acts through a selective antiproliferative mechanism of action The regulatory approval of Klisyri®...

Kintor Pharmaceutical Limited (HKEX:9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that Paraguay's Ministry of Public Health and Social Welfare (MSPBS) has granted an...

BioMarin Pharmaceutical Inc. announced today that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe...

Cue Health Inc. ("Cue Health" or "Cue"), a healthcare technology company, today announced it has received regulatory approval from The Central Drugs Standard Control Organisation (CDSCO) for the Cue COVID-19 Test for professional point-of-care use in...

THC BioMed Intl Ltd. ("THC BioMed" or the "Company" is pleased to announced that its Health Canada Licence has been  amended to include 3 additional strata units at its Acland road location. The 3 strata units include a new storage area for edibles...

Dermadry, a company based in Montreal, Cananda, that created a medical device to treat excessive sweating, is pleased to announce that it has obtained the CE Marketing for their medical device, Iontophoresis, which allows them to deploy their device...

Provention Bio, Inc. , a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that teplizumab, an anti-CD3 monoclonal antibody (mAb), was awarded an Innovation Passport for the delay of clinical...

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...