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...
Lonza to buy large-scale biologics Vacaville site from Roche for USD 1.2 billion Ruchika Sharma25 March 2024 10:00 AM ISTBasel: Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, has announced it has signed an agreement...
CDSCO Panel Grants Roche's Protocol Amendment Proposal For Crovalimab study Dr. Divya Colin16 March 2024 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Roche Pharma unveils multiple sclerosis treatment drug Ocrevus in India Ruchika Sharma29 Feb 2024 5:00 PM ISTNew Delhi: Roche Pharma India has launched a drug for the treatment of Multiple Sclerosis (MS), expanding its neurology portfolio to cater...
CDSCO Panel Approves Roche's protocol amendment proposal for anti-cancer drug Atezoluzumab study Dr. Divya Colin25 Feb 2024 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
CDSCO Panel Grants Roche's Protocol Amendment Proposal For Anti-cancer Drug Giredestrant Dr. Divya Colin24 Feb 2024 5:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
