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300 News Found

Neurizon’s ALS drug regimen cleared for launch in Healey platform trial
Clinical Trials | December 12, 2025

Neurizon’s ALS drug regimen cleared for launch in Healey platform trial

The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled


Teva files FDA application for once-monthly schizophrenia injection
Drug Approval | December 11, 2025

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time


AbbVie’s Atogepant shows breakthrough results for acute migraine relief
Clinical Trials | December 03, 2025

AbbVie’s Atogepant shows breakthrough results for acute migraine relief

Suffering from acute migraine? You may soon bid adieu to the debilitating headache


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


Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay
Drug Approval | November 30, 2025

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026


Zydus inks licensing, commercialisation pact with RK Pharma
News | November 27, 2025

Zydus inks licensing, commercialisation pact with RK Pharma

RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US


Novo Nordisk fast-tracks higher-dose obesity drug to FDA
Clinical Trials | November 27, 2025

Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway


Kelun-Biotech’s Sac-TMT shows breakthrough results in first-line lung cancer trial
Clinical Trials | November 27, 2025

Kelun-Biotech’s Sac-TMT shows breakthrough results in first-line lung cancer trial

Sac-TMT is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors


Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia
Biopharma | November 25, 2025

Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia

The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval