News by subject: IMA

-  XPOVIO®, in combination with bortezomib and dexamethasone (XBd), gives patients with relapsed and/or refractory multiple myeloma, a new treatment option. -  XPOVIO®, in combination with dexamethasone (Xd), gives patients with triple class...

Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company dedicated to the development of innovative antibody drugs, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved...

RedCloud Bio (the "Company"), an innovative biotech company integrating structural pharmacology and computational approaches to advance small molecule drug development, announced today that the US Food and Drug Administration (FDA) has accepted the...

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

Diadem Srl today announced CE IVD certification for its AlzoSure® Predict prognostic blood test for the early prediction of Alzheimer's disease (AD). The CE IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification allows Diadem to...

Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and...

Brand Institute is proud to announce its successful partnership with Global Blood Therapeutics (GBT) in naming their EMA-approved therapy, OXBRYTA, indicated for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and...

Technology has become a lucrative part of the healthcare industry as providers increasingly realize the role it can play in helping them provide better care. For the architects and developers involved in creating these new, high-tech healthcare...

CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convideciatm) has been approved by the Joint Prevention and Control...

BIMZELX® (bimekizumab injection) is the first treatment for adults with moderate to severe plaque psoriasis that is designed to inhibit both IL-17A and IL-17F inhibitor to be approved by Health Canada. Approval is supported by three Phase III trials,...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Health Canada has granted authorization for Nuvaxovidtm COVID-19 Vaccine (Recombinant...

Today, Health Canada authorized Novavax's Nuvaxovid COVID-19 vaccine for the prevention of COVID-19 in adults 18 years of age and older. This is the fifth COVID-19 vaccine authorized in Canada. After a thorough, independent review of the evidence,...

TytoCare, the global health care industry's first all-in-one modular device and examination platform for AI-powered, on-demand, remote medical exams, announced today that it received CE Mark approval for its AI-backed Tyto Lung Sounds Analyzer. The...

Volpara Health is proud to announce that it has been granted a patent on a new method for the detection and quantification of breast arterial calcifications (BACs), by the US Patent and Trademark Office (patent number 11,246550). The method described...

AffaMed Therapeutics ("AffaMed"), a global clinical stage biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products, today announced that the United States Food and Drug...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Singapore Health Sciences Authority (HSA) has issued interim authorization for...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional...

PLT Health Solutions, Inc. today announced that Earthlight® Whole Food Vitamin D has received approval from the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária: ANVISA), paving the way for this unique dietary ingredient...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the Russian one-shot Sputnik Light vaccine against coronavirus has been authorized by the Drug Controller General of India (DCGI)....

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces that the Russian Sputnik V vaccine against coronavirus has been granted full permanent approval by Russia's Health Ministry. It had previously...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted provisional approval of NVX-CoV2373, Novavax'...

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...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing...

GlobalMed, an international provider of virtual health solutions, is proud to announce that its eNcounter® telehealth software suite, ClinicalAccess® Station Lite and multiple diagnostic examination cameras are now compliant to the European Union's...

Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function in children aged 6 to 11 years Dupixent is the only biologic to show improved lung function in a randomized Phase 3...

Blueprint Medicines Corporation today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending to expand the current indication for AYVAKYT® (avapritinib)...

Lilly Canada is pleased 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 announced...

Nippon Express (Belgium) N.V./S.A. (hereinafter "NX Belgium"), a company of the Nippon Express Holdings, Inc. Group, has obtained Good Distribution Practice (GDP) certification, effective December 21, 2021, for air and ground forwarding operations,...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Australia's Therapeutic Goods Administration (TGA) has granted approval for...

Qilian International Holding Group Limited (the "Company", "Qilian International", "we", "our" or "us"), a China-based pharmaceutical and chemical products manufacturer, today announced that the Company received approval from Gansu Provincial Drug...

On December 7, 2021, MIOK Keratoprosthesis was approved for listing by NMPA, the Chinese agency for regulating drugs and medical devices. MIOK Keratoprosthesis is the world's first ever approved artificial cornea that requires no co-implantation of...

Secondary immunodeficiencies (SIDs) are a group of acquired diseases that cause full or partial impairment of the immune system, leaving patients at increased risk of severe...

Pfizer Canada announced today that Health Canada has authorized the use of PAXLOVIDtm (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate...

Seegene Inc. (KQ 096530), South Korea's leading molecular diagnostic company, announced it has received approval of its Allplextm SARS CoV-2 FluA/FluB/RSV Assay under Health Canada's Interim Order on January 11. Seegene's Allplextm SARS CoV-2...

- Floodlight MS complies with the new EU Medical Device Regulation (MDR), reinforcing confident use by patients and their healthcare providers - MDR certification provided by an independent notified body confirms Floodlight MS meets high standards of...

SiliCycle Inc., a company working in the health field, founded and established in Quebec, takes a major step allowing it to directly reach medical customers. The company has obtained approval to sell directly to consumers with a prescription for...

Sight Diagnostics, the company delivering lab-grade Complete Blood Count (CBC) results in minutes, today announced it has received Health Canada approval to provide Sight OLO® analyzers for point-of-care settings. Through its distribution partner...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today...

Ascletis Pharma Inc. (HKEX: 1672) announces today the filing of the U.S. Investigational New Drug (IND) application for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors. ASC61 is an oral...

CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) announced that the National Medical Products Administration of China ("NMPA") granted approval for its ACYW135 Meningococcal Conjugate Vaccine (CRM197) ("MCV4", trade name: Menhyciatm),...

AliveCor's KardiaMobile® is the only personal electrocardiogram (ECG) to be recommended by the National Institute for Health and Care Excellence (NICE) for use within the NHS[1] NICE's positive recommendation[1] offers patients and physicians across...

In a significant move to fight COVID-19 and other contagious pathogens in health care settings, the U.S. Environmental Protection Agency (EPA) has granted Sterifre Medical, Inc. registration to begin commercial deployment of the company's novel,...

Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announces that a positive decision has been made by the European Medicines Agency (EMA) on the Paediatric Investigation Plan (PIP) for leniolisib, a phosphoinositide...

Diamond Therapeutics Inc. ("Diamond"), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, commends Health Canada's decision to reverse regulatory changes made to the Special Access Program...

Biohaven Pharmaceutical Holding Company Ltd. and Pfizer Inc. , today announced that the parties have completed the collaboration transaction between the two companies. The transaction agreements, including Pfizer's commercialization of rimegepant...

SpliSense, a biopharmaceutical company developing transformative mRNA-altering therapies for cystic fibrosis (CF) and other pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)...

AMDT Holdings, Inc. located in Collierville, Tennessee is pleased to announce recent receipt of Notice of Allowances from the China National Intellectual Property Administration and the Australian Patent Office, and the issuance of Japanese Patent...

Dynavax Technologies Corporation  a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Biological E reported that CORBEVAXtm, their COVID-19 vaccine which contains Dynavax's CpG 1018® adjuvant, received...