FDA grants priority review to Merck’s new biologics license application for V116
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
Lacosamide is indicated to treat partial-onset seizures
Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body
Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell
The product will be manufactured at Lupin's Pithampur facility in India
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
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