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Results For "FDA"

2062 News Found

Zydus receives final approval from the USFDA for Lacosamide Tablets
Drug Approval | December 18, 2023

Zydus receives final approval from the USFDA for Lacosamide Tablets

Lacosamide is indicated to treat partial-onset seizures


Zydus receives final approval from the USFDA for Darunavir Tablets 600 mg and 800 mg
News | December 17, 2023

Zydus receives final approval from the USFDA for Darunavir Tablets 600 mg and 800 mg

Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body


Zydus receives final USFDA approval for Cyclophosphamide Capsules USP, 25 mg and 50 mg
Drug Approval | December 17, 2023

Zydus receives final USFDA approval for Cyclophosphamide Capsules USP, 25 mg and 50 mg

Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell


Lupin receives USFDA approval for Allopurinol Tablets
Drug Approval | December 17, 2023

Lupin receives USFDA approval for Allopurinol Tablets

The product will be manufactured at Lupin's Pithampur facility in India


FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B
Drug Approval | December 13, 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

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


Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis
Drug Approval | December 10, 2023

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis

Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections


Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease
Drug Approval | December 09, 2023

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions


Zydus receives final approval from the USFDA for methylene blue injection
Drug Approval | December 07, 2023

Zydus receives final approval from the USFDA for methylene blue injection

Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product


Lupin receives approval from U.S. FDA for Varenicline Tablets
News | December 07, 2023

Lupin receives approval from U.S. FDA for Varenicline Tablets

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.