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Results For "FDA"

1722 News Found

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US
Drug Approval | September 03, 2024

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA


Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan
News | August 30, 2024

Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan

Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025


Bayer starts Phase III trial in non-small cell lung cancer
Diagnostic Center | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA
Diagnostic Center | August 26, 2024

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India


Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program
News | August 21, 2024

Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program

Rad-Sure blood irradiation indicators are FDA 510 (k) cleared medical devices that offer positive visual verification of irradiation at the minimum specified dose


Granules India receives ANDA approval for Glycopyrrolate Oral Solution
Drug Approval | August 20, 2024

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients


Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer
Drug Approval | August 17, 2024

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone


Novo Nordisk's H1 sales increased by 24% in Danish kroner
News | August 12, 2024

Novo Nordisk's H1 sales increased by 24% in Danish kroner

For the 2024 outlook, sales growth is now expected to be 22-28% at CER


Wockhardt Q1 FY25 revenue up 14%
News | August 12, 2024

Wockhardt Q1 FY25 revenue up 14%

EBITDA for Q1 FY25 is at Rs. 100 crore compared to Rs. 32 crore in the previous year


Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr
News | August 12, 2024

Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr

Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore