News
The most recent news and industry headlines are presented in this section. Our dedicated team closely observes the pharmaceutical industry and keeps you informed of the most recent developments around the Europe.
Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma
Thursday, May 11, 2023Servier a global pharmaceutical group today announced that the European Commission EC has approved Tibsovo ivosidenib tablets as a targeted therapy in two indications in combination with azacitidine for the treatment of adult patients with newly diag...
Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce FDA Approval of ELFABRIO® (pegunigalsidase alfa-iwxj) for the Treatment of Fabry Disease
Thursday, May 11, 2023Chiesi Global Rare Diseases a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases and Protalix BioTherapeutics Inc NYSE AmericanPLX a biopharmaceutical company focused on th...
Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of supplemental New Drug Application
Thursday, May 11, 2023Otsuka Pharmaceutical Co Ltd Otsuka and H Lundbeck AS Lundbeck announce the US Food and Drug Administration FDA has approved the supplemental New Drug Application sNDA of REXULTI brexpiprazole for use in the treatment of agitation associated with dem...
Amgen And Tscan Therapeutics Announce Collaboration To Identify Novel Targets In Crohns Disease
Thursday, May 11, 2023Amgen NASDAQAMGN and TScan Therapeutics Inc NASDAQTCRX today announced a multiyear collaboration that will use TScans proprietary target discovery platform TargetScan to identify the antigens recognized by T cells in patients with Crohns disease Unde...
The China NMPA Approves TYVYT® (sintilimab injection) in Combination with Bevacizumab and Chemotherapy in Patients with EGFR-mutated Non-squamous NSCLC who Progressed after EGFR-TKI Therapy
Wednesday, May 10, 2023Innovent Biologics Inc Innovent HKEX a worldclass biopharmaceutical company that develops manufactures and commercializes highquality medicines for the treatment of cancer autoimmune metabolic ophthalmology and other major diseases and Eli Lilly and...
Ultomiris approved in the EU for adults with neuromyelitis optica spectrum disorder (NMOSD)
Wednesday, May 10, 2023Ultomiris ravulizumab has been approved in the European Union EU as the first and only longacting C complement inhibitor for the treatment of adult patients with antiaquaporin AQP antibodypositive Ab neuromyelitis optica spectrum disorder NMOSD
Singlera Genomics Receives FDA Breakthrough Device Designation for PDACatch, a Liquid Biopsy Assay for Pancreatic Cancer Detection in High-Risk Individuals
Tuesday, May 09, 2023Singlera Genomics a company focused on the application of novel DNA methylation technologies to genetic diagnosis today announced that it had received Breakthrough Device Designation from the Food and Drug Administration FDA for its PDACatch assay a...
FDA accepts application for Roches Vabysmo for the treatment of retinal vein occlusion (RVO)
Tuesday, May 09, 2023Roche SIX RO ROG OTCQX RHHBY announced today that the US Food and Drug Administration FDA has accepted the companys supplemental Biologics License Application sBLA for Vabysmo faricimab for the treatment of macular edema following retinal vein occlus...
Long Grove Pharmaceuticals Secures Commercial Rights to an Essential Critical Care Medication
Friday, May 05, 2023Long Grove Pharmaceuticals announced the strategic inlicensing of Norepinephrine in Sodium Chloride premix formulation from Nevakar Injectables Inc This manufactured readytouse formulation is roomtemperature stable and will be available in three com...
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
Thursday, May 04, 2023The US Food and Drug Administration approved Arexvy the first respiratory syncytial virus RSV vaccine approved for use in the United States Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals years o...
