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Dr Reddy s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

In January 2023, the company had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate DRL RI, with the intention to file in the United States, European Union and other regions Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review

Andhra pradeshUnited kingdomUnited statesJayanth sridharFresenius kabiExchange commissionReddy laboratories ltdRegulatory agencyEuropean medicines agencyEuropean unionGood health cant waitDrug administrationBiologics license applicationGlobal headLow tumour burden follicular lymphomaGood health cant wait

Rituximab: USFDA accepts Dr Reddy s rituximab biosimilar candidate DRL_RI for substantive review | India News

Rituximab: USFDA accepts Dr Reddy s rituximab biosimilar candidate DRL_RI for substantive review | India News
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United kingdomAndhra pradeshJayanth sridharEuropean medicines agencyDr reddy laboratories ltd onDrug administrationDr reddy labRegulatory agencyLaboratories ltd

Dr Reddy s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

In January 2023, the company had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate DRL RI, with the intention to file in the United States, European Union and other regionsFollowing dossier submission in April 2023, the regulatory agencies have now.

Andhra pradeshUnited kingdomUnited statesJayanth sridharFresenius kabiEuropean medicines agencyExchange commissionDrug administrationReddy laboratories ltdRegulatory agencyEuropean unionGood health cant waitBiologics license applicationGlobal headLow tumour burden follicularGood health cant wait

Dr Reddy s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab

Tocilizumab is an important anti-rheumatic agent used in the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more. | June 5, 2023

United statesAndhra pradeshReddy tocilizumabJayanth sridharTocilizumab roactemraTocilizumab actemraReddy laboratories ltdExchange commissionChugai seiyaku kabushiki kaisha corpGood health cant waitRoche groupDouble blindComparative pharmacokineticPharmacodynamic studyReference tocilizumabIntravenous route

Dr Reddy s successfully completes Phase I study (IV route) of DRL_TC, a proposed biosimilar of tocilizumabp

Dr. Reddy s Laboratories Ltd. , a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL TC, successfully met its primary and secondary endpoints in a Phase I study.

United statesReddy tocilizumabTocilizumab roactemraTocilizumab actemraJayanth sridharReddy laboratoriesReddy laboratories ltdDouble blindComparative pharmacokineticPharmacodynamic studyReference tocilizumabIntravenous routeNormal healthy male volunteerGlobal headLaboratories limited