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Results For "NDA"

4487 News Found

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


Odisha to implement AB PM-JAY scheme
News | January 14, 2025

Odisha to implement AB PM-JAY scheme

The scheme is fully digitized and covers approximately 45% of India's population


Cube Biotech acquires IBA Lifesciences
News | January 14, 2025

Cube Biotech acquires IBA Lifesciences

The combined entity will leverage its complementary strengths to deliver unparalleled solutions in protein purification and stabilization


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer
Clinical Trials | January 13, 2025

Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer

If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population