Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements

Bayer advances fight against rare kidney disease with new experimental drug

Alport Syndrome is caused by genetic mutations affecting type IV collagen in the kidneys, ears, and eyes

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US

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

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

NATCO Pharma receives 7 observations from USFDA for API unit at Manali