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Results For "NDA"

4491 News Found

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator
News | January 23, 2026

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance


EMA hits record high in vet medicine nods for second year running
News | January 23, 2026

EMA hits record high in vet medicine nods for second year running

EMA recommended 30 veterinary medicines for marketing authorisation in 2025


iRegene’s Parkinson’s therapy gains FDA designation
News | January 21, 2026

iRegene’s Parkinson’s therapy gains FDA designation

The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases


Lupin and Galenicum ink license and supply agreement for semaglutide in 23 countries
News | January 21, 2026

Lupin and Galenicum ink license and supply agreement for semaglutide in 23 countries

Galenicum will oversee development, manufacturing and supply, while Lupin will handle regulatory submissions, approvals, and commercialization and distribution of Semaglutide across 23 countries globally


Senores Pharmaceuticals reports stellar Q3 FY26 growth; PAT surges 105%
News | January 21, 2026

Senores Pharmaceuticals reports stellar Q3 FY26 growth; PAT surges 105%

In Q3 FY26, Senores posted consolidated revenue of Rs. 175 crore, up 64% year-on-year.


FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer
Drug Approval | January 21, 2026

FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer

Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells


Max Institute partners with Intuitive Surgical to expand robotic-assisted surgery in India
News | January 21, 2026

Max Institute partners with Intuitive Surgical to expand robotic-assisted surgery in India

The collaboration will focus on enhancing surgeon capabilities, developing structured training pathways, and promoting the adoption of robotic-assisted surgery in both routine and complex procedures


AstraZeneca to withdraw Nasdaq listings ahead of NYSE direct listing
News | January 21, 2026

AstraZeneca to withdraw Nasdaq listings ahead of NYSE direct listing

The move follows AstraZeneca’s previously announced plan to complete a direct listing of its Ordinary Shares and debt securities on the New York Stock Exchange


Kindeva appoints David Stevens as new CEO
People | January 20, 2026

Kindeva appoints David Stevens as new CEO

Stevens succeeds Milton Boyer, who has stepped down as CEO but will remain closely involved with the business as an independent member of Kindeva’s Board of Directors