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Results For "NDA"

3739 News Found

GEON Performance Solutions acquires Foster Corporation
News | January 09, 2025

GEON Performance Solutions acquires Foster Corporation

Acquisition expands high-value medical platform


Mitsubishi Tanabe Pharma enters into a sub-licensing agreement for oral spleen tyrosine inhibitor fostamatinib in Taiwan with Kissei Pharmaceutical
News | January 09, 2025

Mitsubishi Tanabe Pharma enters into a sub-licensing agreement for oral spleen tyrosine inhibitor fostamatinib in Taiwan with Kissei Pharmaceutical

This product is an oral SYK inhibitor and suppresses platelet destruction by macrophages and platelet depletion


ProBioGen expands protein and viral manufacturing to drive continued growth
News | January 09, 2025

ProBioGen expands protein and viral manufacturing to drive continued growth

This strategic move aims to address the increasing global demand for biologics, enhancing ProBioGen's ability to support partners from cell line development t


Biocon Biologics embarks on a three-stage strategic journey
News | January 08, 2025

Biocon Biologics embarks on a three-stage strategic journey

Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries


Ajooni Biotech to raise Rs. 45 crore through convertible warrants
News | January 08, 2025

Ajooni Biotech to raise Rs. 45 crore through convertible warrants

These initiatives will strengthen the company’s capital base, providing financial flexibility for future


Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary
News | January 07, 2025

Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary

These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


Quality not just a measure, a way of life that drives innovation:  Renewable Energy Minister Joshi
News | January 07, 2025

Quality not just a measure, a way of life that drives innovation: Renewable Energy Minister Joshi

The cornerstone of the quality ecosystem is the implementation of the Quality Control Orders


1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign
Policy | January 07, 2025

1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign

Nadda chairs Joint Strategy Meeting with Line Ministries for TB Mukt Bharat Abhiyan- 100-Day Intensified Campaign