Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product
Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa
Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States
The company has received Form 483 with three observations
The product is expected to be launched in FY25
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