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5346 News Found

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea
Drug Approval | December 03, 2025

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea

Presbyopia, the age-related loss of near vision, could soon be treated successfully


GV20 Therapeutics hits milestone in AI-driven cancer therapy collaboration with Mitsubishi Tanabe Pharma
News | November 28, 2025

GV20 Therapeutics hits milestone in AI-driven cancer therapy collaboration with Mitsubishi Tanabe Pharma

GV20 received an upfront payment and is eligible for additional milestone payments


Enzymit and Cosun chart breakthrough in cell-free hyaluronic acid production
Biopharma | November 14, 2025

Enzymit and Cosun chart breakthrough in cell-free hyaluronic acid production

Hyaluronic acid is among the world's most valuable biopolymers, with applications spanning from dermal fillers and wound healing to drug delivery and tissue engineering


FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency
Drug Approval | November 06, 2025

FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency

Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA


Sumitomo Pharma America unveils promising new leukemia and myelofibrosis data ahead of ASH 2025
Clinical Trials | November 06, 2025

Sumitomo Pharma America unveils promising new leukemia and myelofibrosis data ahead of ASH 2025

Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis


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


Evofem's SOLOSEC submitted for regulatory approval in the UAE
News | October 06, 2025

Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment


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


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company


AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease
Drug Approval | September 29, 2025

AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease

If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option