Roche Inavolisib gets USFDA priority review for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation Ruchika Sharma29 May 2024 11:30 AM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application and granted Priority...
Head of Roche Pharma Partnering James Sabry to retire Ruchika Sharma27 May 2024 3:30 PM ISTBasel: Roche has announced that James Sabry (1958), Head of Roche Pharma Partnering, will be retiring after fourteen years with the company.James...
Roche gets USFDA Breakthrough Therapy Designation for Inavolisib for breast cancer with mutation Ruchika Sharma21 May 2024 2:30 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an...
FDA approves new self collection test for screening human papillomavirus Dr. Kamal Kant Kohli20 May 2024 5:45 AM ISTThe US FDA has approved a new self-collection test to detect human papillomavirus (HPV) and identify women at risk for cervical cancer. The new test...
USFDA approves Roche HPV self-collection solution in US Ruchika Sharma15 May 2024 1:05 PM ISTBasel: Roche has announced the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United...
USFDA approves Alembic Pharma five products in over a month Ruchika Sharma9 May 2024 1:05 PM ISTMumbai: Alembic Pharmaceuticals Limited announced today that it has received US Food & Drug Administration (USFDA) approvals on five of its...
Roche Alecensa gets USFDA nod for ALK-positive early-stage lung cancer Ruchika Sharma20 April 2024 12:05 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa (alectinib) for adjuvant treatment following...
CDSCO Panel Approves Roche's Protocol Amendment Proposal For Anti-cancer Drug Atezolizumab, Lenvatinib, and Sorafenib Study Dr. Divya Colin14 April 2024 5:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Roche gets CE Mark for companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for Enhertu Ruchika Sharma12 April 2024 12:54 PM ISTTucson: Roche has announced the approval of the CE Mark for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx to identify...
Roche gets USFDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis Ruchika Sharma11 April 2024 5:47 PM ISTBasel: Roche has announced that its Elecsys pTau217 assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration...
Roche gets USFDA approval for molecular test to screen for malaria in blood donors Ruchika Sharma30 March 2024 2:30 PM ISTThe cobas Malaria test, a qualitative in vitro nucleic acid screening test, allows for direct detection of Plasmodium RNA and DNA in whole blood...
Recalculate sample size based on serious adverse event: CDSCO Panel Tells Roche on Polatuzumab vedotin study Dr. Divya Colin25 March 2024 6:00 PM ISTNew Delhi: In line with the Phase IV clinical trial protocol of Polatuzumab Vedotin for Injection, 30mg/vial and 140 mg/vial, the Subject Expert...
