(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can be fatal without treatment. The approval is based on results from the MANDARA … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Adrian Kemp, AstraZeneca, Dr. Michael Wechsler, Eosinophilic Granulomatosis with Polyangiitis (EGPA), Fasenra, FDA, Joyce Kullman, Ruud Dobber, safety, vasculitis
(IN BRIEF) Royal Philips announces the final agreement on a consent decree for its subsidiary, Philips Respironics, with the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA). The decree primarily focuses on Respironics’ US operations, … Read the full press release
Posted in Business, Electronics & Machinery, Financial, Government, Healthcare, Industrial, Investment, Management, Netherlands, News, Security & Safety, Technology
Tagged DOJ, FDA, Philips, Philips Respironics, Roy Jakobs, safety, Steve C. de Baca
(IN BRIEF) Basilea Pharmaceutica Ltd, a biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for ZEVTERA® (ceftobiprole medocaril sodium for injection). The approval covers its use in adult patients with Staphylococcus aureus bloodstream infections (bacteremia), … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged Adesh Kaul, Basilea, David Veitch, Dr. Marc Engelhardt, FDA, Pediatric Use, safety, Severe Bacterial Infections, Thomas Holland, Vance G. Fowler, Zevtera®
(IN BRIEF) Borealis has received Letters of No Objection (LNOs) from the US Food & Drug Administration (FDA) for specific grades of its Borcycle™ M post-consumer recycled plastics (PCR) to be used in food-grade packaging. This milestone underscores Borealis’ commitment … Read the full press release
(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and … Read the full press release
Posted in Business, Germany, Healthcare, Pharma & Biotech
Tagged #FutureFresenius, Actemra®, autoimmune diseases, Biosimilar, Cancer, cancer treatment, FDA, Food and Drug Administration, Fresenius Kabi, Genentech, Idacio®, inflammatory, inflammatory diseases, IV, IV formulation, Stimufend®, Subcutaneous formulation, subcutaneous tocilizumab biosimilar, tocilizumab, tocilizumab biosimilar, tocilizumab-aazg, Tyenne®
(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release
Posted in Finland, Germany, Healthcare, Insurance, News, Pharma & Biotech, Science, Society, Switzerland, Technology, United Kingdom
Tagged accessible cancer solutions, AstraZeneca, Aviva, BioNTech, breast cancer, breast cancer screening, cancer care, cancer diagnostics, cancer prevention awareness, cancer research, cancer treatment, colorectal cancer, Daiichi Sankyo, datopotamab deruxtecan, Duality Biologics, Eckert & Ziegler, EMA, FDA, genetic risk information, Inspirna, lung cancer, Merck KGaA, multi-cancer early detection, neuroendocrine neoplasms diagnostics, Novartis, ompenaclid, oncology, polygenic risk score, preventive healthcare, Professor Tim Maughan, ReSisTrace methodology, Stage III EGFR-mutated lung cancer, Swiss Re Institute, Tagrisso, treatment-resistant cancer cells, University of Helsinki, University of Liverpool
(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release
Posted in Business, Education, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Adrian Kemp, AstraZeneca, chemotherapy, Dave Fredrickson, EGFR-mutated lung cancer, FDA, Laurie Ambrose, Pasi A. Jänne, Tagrisso
(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate, BNT323/DB-1303. The designation is for the treatment of advanced endometrial cancer in patients who have progressed following immune checkpoint inhibitor … Read the full press release
Posted in Germany, Healthcare, Pharma & Biotech, Technology
Tagged advanced endometrial cancer, antibody-drug conjugate, BioNTech SE, BNT323, Breakthrough Therapy, DB-1303, Duality Biologics, DualityBio, endometrial cancer, FDA, HER2, Human Epidermal Growth Factor Receptor 2, Prof. Özlem Türeci M.D., uterine cancer, Vivian Gu M.D.
(IN BRIEF) Roche, a leading healthcare company, has announced that its Elecsys Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The Elecsys NfL test is designed … Read the full press release
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged Elecsys NfL Test, FDA, Matt Sause, multiple sclerosis, Roche
(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor VIII replacement therapy used to control bleeding in patients with hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, stands out … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science
Tagged ALTUVIIIO, authorization, bleeding, Brian Foard, efanesoctocog alfa, FDA, hemophilia A, Japan, marketing, MHLW, partnership, Sanofi, Sobi, treatment
(IN BRIEF) AstraZeneca’s new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review by the US FDA for the treatment of advanced breast cancer. The NDA is being reviewed under Project Orbis, which … Read the full press release
Posted in Healthcare, Pharma & Biotech, United Kingdom
Tagged 2022 San Antonio Breast Cancer Symposium, AstraZeneca, breast cancer, CAPItello-291 Phase III, capivasertib, CDK4/6 inhibitors, endocrine therapies, Faslodex, FDA, Food and Drug Administration, fulvestran, hormone receptor, metastatic breast cancer, NDA, New Drug Application, Priority Review, Susan Galbraith, The New England Journal of Medicine
(NOTIZIA IN BREVE) La Banca europea per gli investimenti (BEI) ha investito 15 milioni di euro in Neuromod Devices Ltd per supportare la commercializzazione del suo dispositivo per il trattamento dell’acufene, Lenire. Il dispositivo ha ottenuto l’approvazione De Novo dalla … Read the full press release
Posted in Banks, European Union, Financial, Healthcare, Investment, Ireland, Pharma & Biotech
Tagged Alessio Beverina, bimodal neuromodulation device, De Novo, dispositivo di neuromodulazione bimodale, dispositivo medico, dispositivo per il trattamento dell'acufene, Dr. Manus Rogan, Dr. Ross O’Neill, European Investment Bank, FDA, Fountain Healthcare Partners, Lenire, medical device, Neuromod Devices Ltd, neuromodulation, neuromodulazione, Panakès Partners, Scientific Reports, TENT-A1, TENT-A2, Thomas Östros, tinnitus, tinnitus treatment device
(IN BRIEF) The European Investment Bank (EIB) has invested €15 million in Neuromod Devices Ltd to support the commercialization of its tinnitus treatment device, Lenire. The device has been granted De Novo approval from the US FDA and has shown … Read the full press release
Posted in Banks, European Union, Financial, Healthcare, Investment, Ireland, Pharma & Biotech
Tagged Alessio Beverina, bimodal neuromodulation device, De Novo, Dr. Manus Rogan, Dr. Ross O’Neill, European Investment Bank, FDA, Fountain Healthcare Partners, Lenire, medical device, Neuromod Devices Ltd, neuromodulation, Panakès Partners, Scientific Reports, TENT-A1, TENT-A2, Thomas Östros, tinnitus, tinnitus treatment device
The company announces FDA clearance for its Alzheimer’s disease Cerebrospinal Fluid (CSF) assays The Elecsys® Alzheimer’s disease (AD) CSF assays will be available on the cobas fully automated immunoassay analyzers, enabling patients to get broad access to high quality testing in a timely … Read the full press release
Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged Alzheimer, beta-amyloid, biomarkers t, CT scan, diagnosis, Elecsys AD CSF Abeta42, Elecsys AD CSF assays, FDA, MRI, pTau181 assays, Roche, tau proteins, Thomas Schinecker
La compañía anuncia la aprobación de la FDA para sus ensayos de líquido cefalorraquídeo (LCR) para la enfermedad de Alzheimer Los ensayos Elecsys® para la enfermedad de Alzheimer (EA) en LCR estarán disponibles en los analizadores de inmunoensayo totalmente automatizados … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, Science, Switzerland, Technology
Tagged Alzheimer, beta-amiloide, biomarcadores t, Diagnóstico, Elecsys AD CSF Abeta42, Elecsys Ensayos AD LCR, Elecsys® beta-amiloide, Elecsys® Phospho-Tau, FDA, patología de Alzheimer, proteínas tau, pTau181 ensayos, resonancia magnética, Roche, Thomas Schinecker, tomografía computarizada
The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance. This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing … Read the full press release
Le test qualitatif cobas SARS-CoV-2 est l’un des premiers tests PCR COVID-19 effectués sur une plateforme automatisée à haut débit à recevoir l’autorisation FDA 510(k). Cette autorisation de la FDA garantira que la communauté des soins de santé a accès … Read the full press release
(PRESS RELEASE) HOERSHOLM, Denmark, 12-Sep-2022 — /EuropaWire/ — Chr Hansen Holding A/S (CPH: CHR), a Danish bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries, has announced new regulatory approvals around the world for … Read the full press release
Posted in Denmark, Food & Beverage, Healthcare, Pharma & Biotech, Science
Tagged 2’-FL, 2’-fucosyllactose, 3-FL, 3-fucosyllactose, 3’-sialyllactose, 3’-SL, 6’-sialyllactose, 6’-SL, breast milk, breastfeeding, Chr. Hansen, EFSA, European Food Safety Authority, FDA, Generally Recognized as Safe, GRAS, hepatology, HMOs, Human Milk Oligosaccharides, infant formula, infant health, infant microbiome science, Jesper Sig Mathiasen, lacto-N-tetraose, LNT, NASPGHAN 2022, Novel Food approval, Nutrition, pediatric gastroenterologists, pediatric gastroenterology, WHO, World Health Organization
(PRESS RELEASE) LONDON, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON: GSK), a British multinational science-led healthcare company, has announced the third major regulatory milestone for its daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of … Read the full press release
(COMMUNIQUÉ DE PRESSE) LONDRES, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON : GSK), une multinationale scientifique britannique , a annoncé la troisième étape réglementaire majeure pour son daprodustat, un inhibiteur oral du facteur prolyl hydroxylase inductible par l’hypoxie (HIF-PHI), pour le … Read the full press release
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