Merck unveils first human data for Alzheimer’s candidates

The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration

Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data

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

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

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

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

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

SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements

Zydus receives FDA’s tentative approval for Empagliflozin and Linagliptin tablets

Merck KGaA’s Cladribine capsules gain FDA fast track for rare neuromuscular disorder