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Results For "FDA"

1722 News Found

Korea’s MFDS completes inspection at Concord Biotech's Dholka unit
Drug Approval | February 21, 2025

Korea’s MFDS completes inspection at Concord Biotech's Dholka unit

The inspection was successfully completed


Innocan Pharma granted first patent in India for its Liposomal CBD Injection
News | February 20, 2025

Innocan Pharma granted first patent in India for its Liposomal CBD Injection

Innovative chronic pain treatment receives IP protection in India's $55 billion pharmaceutical market


Lupin Q3 FY25 profit up 40% at Rs. 855 Cr
News | February 14, 2025

Lupin Q3 FY25 profit up 40% at Rs. 855 Cr

Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


Aurbindo Pharma posts Q3 FY25 profit at Rs. 846 Cr
News | February 08, 2025

Aurbindo Pharma posts Q3 FY25 profit at Rs. 846 Cr

During the quarter, US formulations revenue decreased by 2.3% YoY to Rs. 3,671 crore.


Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr
News | February 04, 2025

Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr

Our Q3 FY25 revenue was at Rs. 1,384.1 crore with an EBITDA of Rs. 360 crore resulting in a 26% EBITDA margin


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Diagnostic Center | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma
News | February 01, 2025

BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma

Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population


Jubilant Ingrevia commissions new cGMP facility for supplying Niacinamide to global clients
News | January 31, 2025

Jubilant Ingrevia commissions new cGMP facility for supplying Niacinamide to global clients

The new facility, which has a capacity of 5,000 metric tonnes, will manufacture nutraceuticals and dietary-active ingredients for human consumption.