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1672 News Found

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


TÜV SÜD inaugurates € 15 million Laboratory & Training Centre Bengaluru Campus
News | December 17, 2023

TÜV SÜD inaugurates € 15 million Laboratory & Training Centre Bengaluru Campus

Expansion of presence in India with electrical safety, electromagnetic compatibility and medical device biocompatibility, toxicity and microbiology testing and certification services


Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets
Drug Approval | December 14, 2023

Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD


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


Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories
News | December 10, 2023

Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories

Dr. Reddy's Laboratories has been issued a Form 483 with three observations


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


Zepbound is now available in US for adults living with obesity
News | December 09, 2023

Zepbound is now available in US for adults living with obesity

Express Scripts to add Zepbound to National Preferred Formulary