In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND
According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million
Demonstrates vision gains with extended treatment intervals in retinal vein occlusion
Till 30th November 2024, more than 2690 PACS have been given initial approval and 687 Kendras have been opened in PACS
Final decision from the European Commission is anticipated within the coming months
IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy
Aims to become India’s leading cancer testing company
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
For people with relapsed or refractory diffuse large B-cell lymphoma
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
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