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Results For "NDA"

4491 News Found

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Indegene wins 2025 BIG Innovation Award for Hyper-automated AI solution
News | January 18, 2025

Indegene wins 2025 BIG Innovation Award for Hyper-automated AI solution

Hyper-automated AI is a unified framework combining AI, ML, RPA, and NLQ to streamline data extraction, quality management, transformation, and actionable insights - all on a single platform


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


AstraZeneca receives CDSCO approval to launch eculizumab in India
Drug Approval | January 17, 2025

AstraZeneca receives CDSCO approval to launch eculizumab in India

Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

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


Dr. Kathiresan Rajasekar appointed President – International Business, Gufic Biosciences
People | January 16, 2025

Dr. Kathiresan Rajasekar appointed President – International Business, Gufic Biosciences

With over 28 years of experience in the pharmaceutical industry, he is a seasoned Techno? Commercial professional and accomplished top management leader


USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs
Policy | January 16, 2025

USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs

The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats


Need for inter-sectoral collaboration, enhanced research, and innovative practices to address growing burden of NCDs: Health Secretary Srivastava
Public Health | January 15, 2025

Need for inter-sectoral collaboration, enhanced research, and innovative practices to address growing burden of NCDs: Health Secretary Srivastava

The conference featured comprehensive discussions, field visits, and knowledge-sharing sessions addressing different aspect of major NCDs


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid