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Drug Approval | February 10, 2025
Briefs: Caplin Point Laboratories, Hikal and Cipla
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
During the quarter, US formulations revenue decreased by 2.3% YoY to Rs. 3,671 crore.
Our Q3 FY25 revenue was at Rs. 1,384.1 crore with an EBITDA of Rs. 360 crore resulting in a 26% EBITDA margin
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
The new facility, which has a capacity of 5,000 metric tonnes, will manufacture nutraceuticals and dietary-active ingredients for human consumption.
Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
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