Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs

SK Biopharmaceuticals acquires exclusive global rights for WARF cancer drug candidate

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category

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

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI

This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States

Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies

GLP-1 therapies are among the fastest-growing drug classes worldwide, projected to drive a $95 billion obesity market by 2030

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

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

FDA nod to AstraZeneca’s Imfinzi plus FLOT chemotherapy for early and locally advanced gastric cancer

Valneva Phase 2 data for Lyme disease vaccine candidate shows striking immune response

Pfizer and Valneva have been collaborating on VLA15’s development and commercialization since April 2020