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Results For "NDA"

5490 News Found

Caplin Point Labs acquires 10 ANDAs, targets $473M US market
News | January 03, 2026

Caplin Point Labs acquires 10 ANDAs, targets $473M US market

The portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025


Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug
Drug Approval | December 17, 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients


FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Novartis appoints Vrinda Taneja as Director – People & Organisation, International India
People | December 14, 2025

Novartis appoints Vrinda Taneja as Director – People & Organisation, International India

Her journey includes leading HR for large and diverse teams across sales, marketing, corporate functions, and R&D


Industry-academia partnership key to advancing R&D agenda, says Dr. Jitendra Singh
R&D | December 05, 2025

Industry-academia partnership key to advancing R&D agenda, says Dr. Jitendra Singh

Growing patent filings and tier-2 innovators reflect expanding national research base


LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea
Drug Approval | December 03, 2025

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea

Presbyopia, the age-related loss of near vision, could soon be treated successfully


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


Lupin Foundation bags CRISIL's Highest VO 1A rating for Excellence in Social Responsibility
News | November 29, 2025

Lupin Foundation bags CRISIL's Highest VO 1A rating for Excellence in Social Responsibility

This distinction is testament to LHWRF's dedication to excellence, transparency, and impact in the realm of social responsibility


Bayer’s experimental stroke drug could reshape secondary stroke prevention
Clinical Trials | November 24, 2025

Bayer’s experimental stroke drug could reshape secondary stroke prevention

Millions of stroke survivors across the world may soon have a new defense


Revvity launch new somatic cancer reference standards to to boost precision in oncology diagnostics
R&D | November 12, 2025

Revvity launch new somatic cancer reference standards to to boost precision in oncology diagnostics

The new MimixTM GeniTM reference standards were developed from the extensively tested Genome-in-a-Bottle Consortium (GIAB) cell line