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Results For "NDA"

4218 News Found

SOUKYA launches Rs. 125 crore, 100-bed AYUSH hospital in Bengaluru
Hospitals | November 10, 2025

SOUKYA launches Rs. 125 crore, 100-bed AYUSH hospital in Bengaluru

The upcoming facility marks a strategic milestone in SOUKYA’s mission to make evidence-based holistic healthcare


Johnson & Johnson gets FDA nod for new depression treatment
Drug Approval | November 10, 2025

Johnson & Johnson gets FDA nod for new depression treatment

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials


Touchlight unveils next-gen circular DNA portfolio for advanced gene therapies
Biotech | November 10, 2025

Touchlight unveils next-gen circular DNA portfolio for advanced gene therapies

The expanded mbDNA portfolio delivers enhanced stability, reduced immunogenicity, and broad compatibility with gene insertion and expression technologies


Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer
Clinical Trials | November 10, 2025

Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026


Venus Remedies expands ASEAN presence with new drug approvals in Vietnam
News | November 10, 2025

Venus Remedies expands ASEAN presence with new drug approvals in Vietnam

Venus Remedies now has 29 active product approvals in Vietnam alone


Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'
Drug Approval | November 10, 2025

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases


Alembic announces USFDA final approval for Dasatinib Tablets
Drug Approval | November 08, 2025

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets


Zydus Lifesciences secures FDA tentative approval for Olaparib tablets
Drug Approval | November 08, 2025

Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers


Alembic receives FDA final approval for Sumatriptan Injection USP
Drug Approval | November 08, 2025

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine