News by subject: IMA

Health Canada filing marks first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities in Canada Submission of all modules required for regulatory review, including CMC and clinical data, are now complete for European...

Akeso Biomedical, Inc., announced today that the company has obtained authorization in the European Union to market CI-FER® as a zootechnical feed additive for piglets and minor porcine species. Akeso Biomedical is a privately held company developing...

The Li-Fraumeni Syndrome Association (LFSA), dedicated to furthering research and worldwide awareness of the inherited cancer predisposition disorder, celebrates new findings published in the renowned JAMA Oncology journal with implications to better...

Over 400 constituents of the National Academy of Inventors (NAI) will convene in Tampa, Florida on October 31-November 3 for the Tenth Annual Conference of the NAI. The theme of the meeting is "Look Back, Think Forward: Framing the Future of...

Akebia Therapeutics, Inc. , a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its collaborator, Otsuka Pharmaceutical Co., Ltd. (Otsuka), today announced that Otsuka Pharmaceutical...

Oramed Pharmaceuticals Inc. (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced that its majority-owned subsidiary, Oravax Medical Inc. (www.ora-vax.com), has received...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to the Therapeutic Goods Administration (TGA) for...

Pfizer Canada ULC announced that its next generation long-acting growth hormone injection, PrNGENLA® (somatrogon), has been approved by Health Canada. NGENLA is a once-weekly long-acting recombinant human growth hormone, for the long-term treatment...

Libtayo® (cemiplimab) is now approved in Canada for the treatment of adults with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI).2  The approval of Libtayo follows the European Commission (EC)...

Vertex Pharmaceuticals Incorporated (Canada)  today announced that its Supplement to a New Drug Submission for PrTRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) has been accepted for Priority Review by Health Canada for the treatment of...

Medigen Vaccine Biologics Corp (MVC) vaccine candidate, MVC-COV1901, has been recommended by an independent vaccine prioritisation advisory group to be included in the World Health Organisation (WHO) Solidarity Trial Vaccines (STv). Following the...

Emmaus Life Sciences, Inc.  a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced the submission of its application for marketing authorization of Endari® to the United Arab Emirates (U.A.E.)...

Kevin Pereau, TranscendIT Health's Founder and Principal and author of The Digital Health Revolution is back with its sequel, It Takes a Village. The 255-page paperback is now available on Amazon.com (TranscendIT Health). A Kindle eBook is also being...

MedSafety Solutions today announced that it has received the European Union Medical Devices Regulations (EU-MDR) certification as of September 9, 2021. This achievement is a major milestone for MedSafety Solutions in its ongoing mission to provide...

PTC Therapeutics, Inc. today announced that the Brazilian National Health Surveillance Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved the expansion of the indication of Translarnatm (ataluren) to include ambulatory children...

Cerebral blood flow (CBF), which supplies oxygen and nutrients to our brain, is a crucial indicator of brain health. Information from CBF can, therefore, help us diagnose brain disorders. While this information is usually obtained from speckle...

Appreciated by thousands of readers, Rejuvenate Aging Eyes The Miracle of PIE, has made complex medical jargon a breeze for the everyday person. Explaining procedures that can be scary for patients in simple language, it allows people desiring...

Today, LumiraDx , a next-generation point of care diagnostics testing company announced it has received emergency use...

SHENZHEN CHIPSCREEN BIOSCIENCES CO., LTD. (hereinafter referred to as: CHIPSCREEN), a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform,...

InnoCare Pharma (HKEX: 09969) announced today that the Company has received Investigational New Drug (IND) approval from the NMPA for its SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189, which is the...

Novartis Pharmaceuticals Canada Inc. applauds the government of Quebec's decision to provide public reimbursement for Zolgensma® (onasemnogene abeparvovec) for the treatment of children with SMA....

LEO Pharma Inc. announced today the Health Canada approval of Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic...

Alnylam Pharmaceuticals, Inc.  is pleased to announce that GIVLAARI® (givosiran) has now received a positive recommendation for reimbursement from the Canadian Agency for Drugs and Technologies in Health (CADTH). GIVLAARI® is approved by Health...

Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that Health Canada has approved FERRIPROX® (deferiprone) for the treatment of iron overload...

The Lancet Respiratory Medicine, one of the world's best-known peer-reviewed medical journals has published Medigen Vaccine Biologics (MVC) data from its MVC-COV1901 vaccine phase 2 clinical trial which demonstrates promising immunogenicity and...

The Lancet Respiratory Medicine, one of the world's best-known peer-reviewed medical journals has published Medigen Vaccine Biologics (MVC) data from its MVC-COV1901 vaccine phase 2 clinical trial which demonstrates promising immunogenicity and...

Qilian International Holding Group Limited  (the "Company"), a China-based pharmaceutical and chemical products manufacturer, announced that on September 14, 2021, through its subsidiary Gansu Qilianshan Pharmaceutical Co., Ltd. (the "Gansu QLS"), it...

Subtle Medical, a healthcare technology company improving the quality and efficiency of medical imaging, announced today Health Canada/Santé Canada approval for their suite of AI-powered image enhancement solutions. Subtle's vendor-neutral software,...

Sanofi Canada is pleased to announce that Health Canada has approved SARCLISA® in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior...

INOVIO , a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that it has received authorization from...

Medtronic plc , the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for the Hugotm robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. CE Mark approval is for...

Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced the filing of an...

Himalaya Therapeutics ("Himalaya"), a clinical-stage biopharmaceutical company focused on development and commercialization in Greater China, of a novel class of investigational antibody therapeutics for the treatment of solid tumor cancer, which are...

The Mitra® microsampling device from US-based Neoteryx is now approved as a Class B in vitro diagnostic (IVD) medical device by the South African Health Products Regulatory Authority (SAHPRA) in South Africa (ZA). Separations, a ZA-based distributor...

Electromedical Technologies, Inc. (the "Company"), a pioneer in the development and production of bioelectronic devices designed to relieve chronic, intractable and acute pains by using frequencies and electro-modulation, is pleased to announce that...

 - Ryaltris® is a fixed dose combination nasal spray that combines an antihistamine (Olopatadine) with a steroid (Mometasone Furoate) for treatment of allergic rhinitis  - Ryaltris® has been well received by the global medical community for the...

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in Germany. The approval applies to the drug Sedaconda (isoflurane) for administration via the medical device AnaConDa...

Medtronic plc , the global leader in medical technology, today announced it has received CE Mark approval for its radial artery access portfolio, which includes the Risttm 079 Radial Access Guide Catheter and Risttm Radial Access Selective Catheter....

Kevin Pereau, TranscendIT Health's Founder and Principal and author of The Digital Health Revolution is back with its sequel, It Takes a Village. The 255-page paperback is now available on Amazon.com (TranscendIT Health). A Kindle eBook is also being...

-  The UK and Germany are the first two European countries where Klisyri® will be available for prescription. The product has been approved for the treatment of actinic keratosis by the UK Medicines and Healthcare products Regulatory Agency (MHRA)...

Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV® (enfortumab vedotin) for radically unresectable...

Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that on September 22 the Brazilian Health Regulatory Agency (ANVISA)...

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 by the Egyptian Drug Authority (EDA). Sputnik Light vaccine is based...

Akeso, Inc. (the Company, 9926.HK) announces that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world's first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research...

Akeso, Inc. (the Company, 9926.HK) announces that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world's first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research...

American Jewish Committee (AJC) welcomes the introduction today of a resolution in the U.S. Senate urging the European Union to designate Hezbollah in its entirety as a terror organization. The bipartisan resolution was introduced by Senators Jacky...

Luye Pharma Group today announced that marketing approval for its innovative formulation Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) has been granted by the UK's Medicines and Healthcare Products Regulatory Agency, for the treatment of...

SAVVYWIRE, the first guidewire that aims to improve procedural efficiency and clinical outcomes for patients undergoing minimally invasive, Trans Aortic Valve Replacement (TAVR)...

Insightec®, a global healthcare company focused on transforming patient care, announced its incisionless neurosurgery platform, the Exablate® 4000, has received market approval by the Central Drugs Standard Control Organization (CDSCO), part of the...

Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated,...