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Results For "New-Drug-Application"

410 News Found

Lupin receives FDA’s tentative approval for Siponimod tablets
Drug Approval | December 05, 2025

Lupin receives FDA’s tentative approval for Siponimod tablets

Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis


FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension
Drug Approval | December 04, 2025

FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension

Here's a development that aims to keep your blood pressure in check. Literally!


Belite Bio reports landmark phase 3 success for Stargardt Disease therapy
Clinical Trials | December 03, 2025

Belite Bio reports landmark phase 3 success for Stargardt Disease therapy

Seeing well-controlled Phase 3 data that shows a marked slowing of lesion growth in Stargardt disease is deeply encouraging


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


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


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


Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients
Clinical Trials | November 28, 2025

Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients

The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio


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


Otsuka files FDA application for first-in-class ADHD drug
Clinical Trials | November 27, 2025

Otsuka files FDA application for first-in-class ADHD drug

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor