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Results For "NDA"

4454 News Found

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film
News | October 06, 2025

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes


Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


Infinitus launches MCP server to bring standardized AI interoperability to healthcare
Digitisation | September 29, 2025

Infinitus launches MCP server to bring standardized AI interoperability to healthcare

New infrastructure makes it possible for healthcare organizations to integrate AI agents seamlessly into critical workflows like benefit verification and prior authorization


Takeda appoints Rhonda Pacheco President of US Business Unit
People | September 13, 2025

Takeda appoints Rhonda Pacheco President of US Business Unit

Rhonda Pacheco to succeed Julie Kim, who was appointed to be Takeda’s next CEO


Biocon Foundation constructs new high school building in Karnataka
News | September 13, 2025

Biocon Foundation constructs new high school building in Karnataka

Biocon Foundation is also expanding its reach with this first initiative in Channapatna region


Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Drug Approval | September 04, 2025

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure


Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement
News | August 17, 2025

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025


Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA
News | August 13, 2025

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA

The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA