Roche to proceed with Phase III development of Prasinezumab in early-stage Parkinson's disease Ruchika Sharma17 Jun 2025 11:00 AM ISTBasel: Roche has announced its decision to proceed with Phase III development of prasinezumab, an investigational anti-alpha-synuclein antibody,...
Roche Evrysdi tablet gets European Commission approval for Spinal Muscular Atrophy Ruchika Sharma5 Jun 2025 2:00 PM ISTBasel: Roche has announced that the European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new,...
Roche Itovebi recommended by CHMP for EU approval for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer Ruchika Sharma25 May 2025 3:30 PM ISTBasel: Roche has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive...
Roche Susvimo gets USFDA green light for Diabetic Retinopathy Ruchika Sharma23 May 2025 10:00 AM ISTBasel: Roche has received approval from the US Food and Drug Administration (FDA) for Susvimo (ranibizumab injection) 100 mg/mL for the treatment...
USFDA Advisory Committee reviews Roche Columvi Combo for diffuse large B-cell Lymphoma Ruchika Sharma21 May 2025 1:45 PM ISTBasel: Roche has announced that a US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the supplemental...
Roche receives USFDA approval for VENTANA MET (SP44) RxDx Assay as companion diagnostic in non-small cell lung cancer Ruchika Sharma18 May 2025 2:30 PM ISTBasel: Roche has announced that the FDA has approved the VENTANA MET (SP44) RxDx Assay, the first companion diagnostic approved to aid in determining...
Zealand Pharma announces closing of collaboration, license agreement with Roche Ruchika Sharma11 May 2025 9:45 AM ISTDenmark: Zealand Pharma A/S, a biotechnology company focused on the discovery and development of peptide-based medicines, has announced that all...
Roche launches Elecsys PRO-C3 test for liver fibrosis Ruchika Sharma6 May 2025 11:30 AM ISTBasel: Roche has announced the launch of its ElecsysPRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in...
EMA Committee recommends EU label update for Roche Phesgo to allow administration outside of clinical settings Ruchika Sharma4 May 2025 1:30 PM ISTBasel: Roche has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive...
Roche secures USFDA Breakthrough Device Designation for AI-driven companion diagnostic for non small cell lung cancer Ruchika Sharma29 April 2025 11:45 AM ISTBasel: Roche has announced that the VENTANA TROP2 (EPR20043) RxDx Device for non-small cell lung cancer has received Breakthrough Device...
Roche gets CE Mark for Chest Pain Triage algorithm Ruchika Sharma25 April 2025 1:30 PM ISTBasel: Roche has announced the introduction of its Chest Pain Triage algorithm as part of the navify Algorithm Suite.Developed in collaboration...
Roche to infuse USD 50 billion in pharma, diagnostics in US over next five years Ruchika Sharma22 April 2025 10:30 AM ISTBasel: Roche has announced today that it will invest USD 50 billion into the United States of America in the next five years. These investments...
