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1469 News Found

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


FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections
News | February 08, 2025

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections

EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA


FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness
Drug Approval | February 05, 2025

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)


Zydus Wellness records consolidated net sales growth of 12.7% in Q3 FY25
News | February 04, 2025

Zydus Wellness records consolidated net sales growth of 12.7% in Q3 FY25

EBITDA rose to Rs. 14.8 crore, marking a 16.5% y-o-y increase, while net profit surged to Rs. 6.4 crore


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025


Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer
Drug Approval | February 01, 2025

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.


Budget 2025: Industry welcomes customs duty exemptions on 36 life-saving drugs and medicines
Policy | February 01, 2025

Budget 2025: Industry welcomes customs duty exemptions on 36 life-saving drugs and medicines

The Union Budget 2025-26 strengthens India's healthcare sector with an allocation of Rs. 99,858.56 crore, marking a 9.78% rise from Rs. 90,958.63 crore in 2024-25


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.


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


Enhertu approved in US for breast cancer post more endocrine therapies
News | January 30, 2025

Enhertu approved in US for breast cancer post more endocrine therapies

Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year