News by subject: IMA

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...

I-Mab (the "Company") , a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products...

According to Yiling Pharmaceutical's notice on Thursday (UTC+8), the Depression-resolving and Restlessness-relieving Capsules have been approved for marketing via the obtained Drug Registration Certificate issued by China's National Medical Products...

Sedana Medical AB (publ) (Stockholm:SEDANA) today announces that the company has submitted an application for market approval for Sedaconda (isoflurane) for inhaled sedation in intensive care in Italy. "With the application in Italy, we are hoping to...

Brand Institute is proud to announce its successful partnership with Novavax in naming their EMA-approved COVID-19 vaccine: NUVAXOVID®. This approval marks the fifth COVID-19 vaccine authorized for use in the European Union. "The entire Brand...

CStone Pharmaceuticals (the "Company" or "CStone") is pleased to announce that the National Medical Products Administration ("NMPA") of China has approved the new drug application ("NDA") of anti-PD-L1 monoclonal antibody Cejemly® (sugemalimab) in...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Medicines Agency (EMA) has recommended granting a...

Antengene Corporation Limited (the "Company" or "Antengene") is pleased to announce that ATG-010 (selinexor, brand name: XPOVIO®), a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound has received conditional approval for...

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 China's National Medical Products...

Global biotherapeutics leader CSL Behring today announced that the Committee for Medicinal Products for Human Use (CHMP), the chief scientific body of the European Medicines Agency (EMA) accepted its request for an accelerated assessment of the...

CSL Behring today announced that the European Medicines Agency (EMA) has granted its approval for an accelerated assessment request for etranacogene dezaparvovec Marketing Authorisation Application (MAA). Etranacogene dezaparvovec is an...

Accuray Incorporated announced today it has received approval from the Japanese Ministry of Health, Labor and Welfare (Shonin) to market the CyberKnife® Robotic Radiosurgery System for the treatment of trigeminal neuralgia (TN) in Japan. The system...

With results ready in 15 minutes, the SARS-CoV-2 Antigen Self Test Nasal increases Canada's testing capacity to detect infections and control outbreaks. The SARS-CoV-2 Antigen Self Test Nasal enables individuals1 to test themselves quickly and...

PharmaMar (MSE: PHM) and partner Jazz Pharmaceuticals plc today announced the initiation of a confirmatory Phase III clinical trial, LAGOON, evaluating Zepzelca® (lurbinectedin) for the treatment of patients with relapsed Small Cell Lung Cancer...

CASI Pharmaceuticals, Inc. , a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announces that the China National Medical Products Administration (NMPA) has approved...

Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant...

Nippon Express (Nederland) B.V. (hereinafter "NEN"), a local subsidiary of Nippon Express Co., Ltd., obtained Good Distribution Practice (GDP) certification, effective September 6, for its company-owned warehouse in Schiphol Trade Park near...

hi-tech health, the leading provider of customized claims administration systems announced the launch of its new redesigned logo and website today. The new visual identity includes evolving our logo by bringing in a bold red and gray. An updated and...

Unique Mode of Action Opaganib works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations, providing a strong rationale for its potential to address the Omicron...

Merck , known as MSD outside Canada and the United States, announced today that it has entered into a Supply Agreement with the Government of Canada for up to 1 million patient courses of molnupiravir, its investigational oral antiviral medicine for...