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1547 News Found

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer
Drug Approval | December 23, 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients


FDA grants priority review to Merck’s new biologics license application for V116
Drug Approval | December 20, 2023

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


Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Drug Approval | December 20, 2023

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection


Lupin receives tentative USFDA approval for Sitagliptin Tablets
Drug Approval | December 18, 2023

Lupin receives tentative USFDA approval for Sitagliptin Tablets

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


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


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