News by subject: IMA

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...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that bevacizumab biosimilar Hanbeitai, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). It is indicated for the treatment...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that bevacizumab biosimilar Hanbeitai, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). It is indicated for the treatment...

Cue Health ("Cue") , a healthcare technology company, today announced it received Pandemic Special Access Route (PSAR) authorization from the Health Sciences Authority (HSA) for the Cue COVID-19 Test for self-testing in Singapore. The Cue COVID-19...

INVO Bioscience, Inc. , a medical device company focused on commercializing the world's only in vivo culture system (IVC), INVOcell®, today announced the Company has received approval by Medical Devices Control Division for FDA Thailand to import and...

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, and...

Esaote ? a leading Italian company in the biomedical sector, in ultrasound, dedicated magnetic resonance imaging and information technology for healthcare ? is pleased to announce that the new Magnifico Open total-body magnetic resonance system has...

Palatin Technologies, Inc. , a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, today announced that the U.S. Patent and Trademark...

SERB and BTG Specialty Pharmaceuticals today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorisation for Voraxaze®...

Today, Corsano Health B.V., a leading MedTech company developing, producing, and marketing medical grade continuous health monitoring announced that it has received the European Union Medical Devices Regulations (EU-MDR) certification for its...

The Council of Global Union (CGU), representing over 200 million workers, has urged UK, Switzerland, Germany and the EU Commission to stop blocking efforts to waive vaccine patents. The largest council of global unions believe action must and can be...

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company focusing on discovering, developing, and manufacturing innovative medicine announced on Oct 26, 2021 that the Office of Orphan Products Development (OOPD) of the U.S. Food...

GlaxoSmithKline Inc. today announced that SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) has been approved in Canada for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of...

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

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older....

NTC Srl, R&D driven pharmaceutical company with headquarters in Italy, and Aspen Pharmacare Holdings Limited ("Aspen"), a South African-headquartered global specialty and branded pharmaceutical company, announced today that the South Africa Health...

Merck , known as MSD outside the United States and Canada, today announced that Health Canada has granted conditional approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy for the treatment of locally...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) today announced the Russian one-shot Sputnik Light vaccine against coronavirus has been approved by the Government of the Republic of San Marino. Sputnik Light vaccine is...

Brain Navi Biotechnology, a Taiwan-based startup specializing in innovative navigation robots, received CE mark approval for brain surgery procedures in Q1 2021 for its NaoTrac, a robotic-assisted surgical robot. As the next step Brain Navi...

Brain Navi Biotechnology, a Taiwan-based startup specializing in innovative navigation robots, received CE mark approval for brain surgery procedures in Q1 2021 for its NaoTrac, a robotic-assisted surgical robot. As the next step Brain Navi...

LifeVoxel.AI, a San Diego based medical platform for AI and Visualization, today announced it has raised a $5 million seed funding. LifeVoxel's patented technologies empower instant and ubiquitous access to interactive imaging studies and data, with...

Sunosi®?(solriamfetol) is the first treatment for adults with excessive daytime sleepiness (EDS) caused by narcolepsy to receive a positive recommendation from NICE Pivotal Phase 3 Treatment of Obstructive sleep apnoea and Narcolepsy Excessive...

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...

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...

Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven") announced today that NURTEC® ODT (rimegepant) was approved by the Kuwait Ministry of Health for the acute treatment of migraine with and without aura in adults. NURTEC ODT is the first and...

Lunit, a leading medical AI provider, today announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest...

HebaBiz Biotech is pleased to announce that in November 2021, the Center for Drug Evaluation (CDE) of The National Medical Products Administration (NMPA) of China has approved the application for phase III clinical study of Clevudine (L-FMAU), a drug...

Nexviazymetm (avalglucosidase alfa for injection) is now approved in Canada for the long-term treatment of patients older than 6 months of age with late-onset Pompe disease (acid ?-glucosidase deficiency).1 Pompe disease is a rare autosomal recessive...

Amgen today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of LUMYKRAS® (sotorasib), known as LUMAKRAS® in the...

Canntab Therapeutics Limited (FRA: TBF1.F) (the "Company" or "Canntab"), the leading innovator in cannabinoid and terpene blends in hard pill form for therapeutic applications, is pleased to announce that it has received its medical sales license...

NUCALA (mepolizumab) is now approved in Canada as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids...

AstraZeneca Canada has initiated a rolling review New Drug Submission with Health Canada for authorization of AZD7442, its long-acting antibody (LAAB) combination, for prevention of symptomatic COVID-19....

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

As reported by Indonesian National Agency of Drug and Food Control (BPOM), BPOM grants the Emergency Use Authorization (EUA) for COVID-19 Vaccine (ChAdOx1-S[recombinant])/KconecaVac manufactured by Shenzhen Kangtai Biological Products Co., Ltd. It is...

Today Bristol Myers Squibb Canada announces two recent Health Canada approvals for OPDIVO® (nivolumab). Unlike traditional cancer therapies that target tumours directly, OPDIVO® activates the body's own immune system to help recognize and attack...

This new indication is based on the EMPEROR-Reduced trial, which showed a significant 25 per cent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization for heart failure with reduced ejection fraction...

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,...