(IN BRIEF) Royal Philips announces the final agreement on a consent decree for its subsidiary, Philips Respironics, with the US…
(IN BRIEF) Basilea Pharmaceutica Ltd, a biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for…
(IN BRIEF) Borealis has received Letters of No Objection (LNOs) from the US Food & Drug Administration (FDA) for specific…
(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations.…
(IN BRIEF) In early 2024, Europe's medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like…
(IN BRIEF) AstraZeneca's Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung…
(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate,…
(IN BRIEF) Roche, a leading healthcare company, has announced that its Elecsys Neurofilament Light Chain (NfL) test for Multiple Sclerosis…
(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor…
(IN BRIEF) AstraZeneca's new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review…
(NOTIZIA IN BREVE) La Banca europea per gli investimenti (BEI) ha investito 15 milioni di euro in Neuromod Devices Ltd…
(IN BRIEF) The European Investment Bank (EIB) has invested €15 million in Neuromod Devices Ltd to support the commercialization of…
The company announces FDA clearance for its Alzheimer’s disease Cerebrospinal Fluid (CSF) assays The Elecsys® Alzheimer’s disease (AD) CSF assays will…
La compañía anuncia la aprobación de la FDA para sus ensayos de líquido cefalorraquídeo (LCR) para la enfermedad de Alzheimer…
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)…
Le test qualitatif cobas SARS-CoV-2 est l'un des premiers tests PCR COVID-19 effectués sur une plateforme automatisée à haut débit…
(PRESS RELEASE) HOERSHOLM, Denmark, 12-Sep-2022 — /EuropaWire/ — Chr Hansen Holding A/S (CPH: CHR), a Danish bioscience company that develops…
(PRESS RELEASE) LONDON, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON: GSK), a British multinational science-led healthcare company, has announced the…
(COMMUNIQUÉ DE PRESSE) LONDRES, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON : GSK), une multinationale scientifique britannique , a annoncé la…
Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010…
(PRESS RELEASE) CAMBRIDGE, 2-Aug-2021 — /EuropaWire/ — AstraZeneca (LON: AZN), a British-Swedish science-led biopharmaceutical company, has announced that its Saphnelo…
(PRESS RELEASE) PARIS, 20-Jul-2021 — /EuropaWire/ — Sanofi (EPA: SAN), a global biopharmaceutical company focused on human health, has announced…
(PRESS RELEASE) VEVEY, 14-Oct-2020 — /EuropaWire/ — Nestlé has successfully closed the acquisition of biopharmaceutical company, Aimmune Therapeutics, Inc. (Nasdaq:…
The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been…
(PRESS RELEASE) CAMBRIDGE, 22-May-2020 — /EuropaWire/ — Enhertu, jointly developed by British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca and the…
(PRESS RELEASE) GENEVA, 26-Mar-2020 — /EuropaWire/ — Inspection, verification, testing and certification company SGS announced it has developed a test…
(PRESS RELEASE) AMSTERDAM, 16-Jan-2020 — /EuropaWire/ — The European Medicines Agency (EMA) appoints Dr Hilmar Hamann as Head of the…
(PRESS RELEASE) GENEVA, 12-Jul-2019 — /EuropaWire/ — SGS launches its new ‘Product Recalls’ digital platform. It is an online database…
EMA, MHRA and FDA among regulatory agencies participating (PRESS RELEASE) BERLIN, 10-Jun-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA)…
BASEL, 18-Jul-2018 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA)…
CINRYZE is the first and only therapy indicated in the U.S. to help prevent angioedema attacks in pediatric patients with…
Workshop with regulators from EU, Japan and US open for registration LONDON, 28-May-2018 — /EuropaWire/ — The European Medicines Agency (EMA),…
Kymriah demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of…
First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable to receive cisplatin chemotherapy…
OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants…
LONDON, 4-5-2015 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental…
Decision could speed access to LCZ696 for HFrEF patients in the US, reducing total review time from 12 to 8…
Second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014 BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO,…
Cincinnati, OH, 28-1-2015 — /EuropaWire/ — Symplmed Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) has approved Prestalia® (perindopril arginine…
With today's approval, Bexsero is now licensed in 37 countries; since first approval in Europe, over 1 million doses have…