News by subject: IMA

Luye Pharma Group has recently been granted official approval by the Saudi Food and Drug Authority to become the Marketing Authorization Holder (MAH) for Seroquel and Seroquel XR in Saudi Arabia. Meanwhile, the new localized packaging for Seroquel...

Pfizer Canada ULC and BioNTech SE today announced that Health Canada has granted full approval (Notice of Compliance or NOC) for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older....

Co-Diagnostics, Inc.  (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for...

Diabeloop, created in 2015, deployed its first Automated Insulin Delivery (AID) system throughout Europe this year. The AI-based personalized solution is currently commercialized in Germany, the Netherlands, Italy, Spain and Switzerland, with more...

Amgen today announced that Health Canada has approved LUMAKRASTM (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have...

AUSTRALIAN patients with an...

Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that Brazil's National Health Surveillance Agency (ANVISA) has approved FERRIPROX®...

Yiling Pharmaceutical recently announced that its newly-developed drug Yishen Yangxin Anshen Tablet had been granted official drug certificate by China's National Medical Products Administration (NMPA). With the functions of reinforcing kidney,...

The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally Currently the only approved CAR-T product that has been simultaneously included in the National...

The European Medicines Agency has issued a marketing authorisation for OZAWADEtm (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea in adults. OZAWADEtm is indicated to improve...

Zymo Research announced today its new line of at-home sample collection kits has received CE marking for sale in the European Union (EU). The SafeCollecttm Sample Collection Kits were designed with consumers' utmost safety in mind for unsupervised...

Sofwave Medical LTD, today announced it has received approval from the Korean Ministry of Foods and Drug Safety (MFDS) to market Sofwavetm its proprietary next-generation Synchronous Ultrasound Parallel Beam technology SUPERBtm for reducing the...

BioMarin Pharmaceutical Inc. announced today that the European Commission (EC) has granted marketing authorization for VOXZOGO® (vosoritide), a once daily injection to treat achondroplasia in children from the age of 2 until growth plates are...

Vertex Pharmaceuticals Incorporated (Canada)  today announced that Health Canada has granted Marketing Authorization for PrKALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) as young as four months of age who have at least one of the...

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...