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Results For "US-FDA"

254 News Found

Healthium Medtech Sri City facility in AP gets U.S. FDA registration
News | December 08, 2021

Healthium Medtech Sri City facility in AP gets U.S. FDA registration

This is the fourth facility from the company to receive this registration


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


Sluggish exports to cap pharma revenue growth at 9% this fiscal
News | November 17, 2021

Sluggish exports to cap pharma revenue growth at 9% this fiscal

A CRISIL study of 207 pharmaceutical companies that account for 55% of the Rs 3.2 lakh crore-a-year sector revenue indicates as much.


Private equity firm Carlyle partners with Viyash Life Sciences for pharma platform
News | November 17, 2021

Private equity firm Carlyle partners with Viyash Life Sciences for pharma platform

Viyash has ten manufacturing facilities in India with a combined capacity of 2000 KL as well as one formulation facility in the US, and is now one of India’s leading mid-tier integrated API and formulation players


Glenmark launches novel fixed-dose combination for diabetes
Drug Approval | October 26, 2021

Glenmark launches novel fixed-dose combination for diabetes

It is the first company to launch Remogliflozin, Vildagliptin and Metformin combination


Healthium Medtech introduces surgical wound dressing product
Startup | October 26, 2021

Healthium Medtech introduces surgical wound dressing product

Expands wound care portfolio and aims to drive greater market penetration and availability in the wound dressing category


Amber Implants VCFix spinal system receives breakthrough designation
Healthcare | October 05, 2021

Amber Implants VCFix spinal system receives breakthrough designation

The first clinical trial is expected to commence in early 2022 both in Europe and the US


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


Prevest DenPro Limited's IPO to open on BSE SME platform on September 15
Diagnostic Center | September 14, 2021

Prevest DenPro Limited's IPO to open on BSE SME platform on September 15

The net proceeds from the issue will be utilised towards the purchase of machinery, modernising existing units and expansion of its R&D facilities


ENTOD Pharma launches surgical division HyTek
Medical Device | September 14, 2021

ENTOD Pharma launches surgical division HyTek

The division will focus on products that are required during ophthalmic surgical procedures like cataracts and refractive surgeries among others