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
The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR
If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse
The product will be manufactured at Lupin’s Somerset facility in the US
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