US FDA grants priority review status to Sanofi’s BLA for avalglucosidase alfa to treat Pompe disease
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term... Read More
What is Biologic License Application (BLA)?
Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who... Read More
Sandoz to launch Amgen’s Enbrel Biosimilar
Sandoz, a Novartis company and the global leader in biosimilars, announced that the US Food and Drug Administration (FDA) has accepted its... Read More