Karuna Therapeutics’ NDA for KarXT accepted by USFDA EP News Bureau Dec 1, 2023 If approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades
Bayer wins US priority review of drug against metastatic prostate cancer Reuters May 5, 2022 With this, the German drugmaker seeks to widen the use of the prostate cancer drug from an early disease stage to metastatic cases
Zydus receives DCGI approval for Oxemia to treat anaemia in CKD patients EP News Bureau Mar 7, 2022 OxemiaTM (Desidustat) is an oral tablet formulation which is the first-in-India alternative to injectable…
Zydus develops new treatment for patients suffering from Chronic Kidney Disease (CKD) EP News Bureau Nov 23, 2021 The company submits first New Drug Application (NDA) to DCGI
FDA approves Dr Reddy’s NDA for migraine drug Press Trust of India May 7, 2020 The company is working to commercialise Elyxyb (previously known as DFN-15), which is indicated for the acute treatment of…
Will NDA-2’s first budget be any different for the pharma sector? Viveka Roychowdhury Jun 27, 2019 With actual fiscal outcomes for FY19 falling short of the revenue estimates put out in the interim budget, FM Sitharaman will have…