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

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

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

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

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

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

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

Mesoblast teams with NIH to launch pivotal trial of life-saving cell therapy in adults with severe aGvHD

The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease

Solara’s Mangalore facility clears FDA inspection with VAI status

Roche wins EU green light for one-minute injection cancer therapy