Biologic drugs have improved how doctors treat serious illnesses. Instead of being made from chemicals, biologics are made from organic materials and grown in living cells. Biologic drugs are used ...

Avalon BioVentures managing partners Sergio Duron and Sandy Madigan hadn’t even left their previous start-up when they hatched the idea for Enlaza Therapeutics. While they were both still at Nerio ...

Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...

Documentary standards such as monographs, general chapters, and reference standards are essential for efficiently meeting regulatory requirements and ensuring the intended efficacy and safety of drugs ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

A West Virginia University legal scholar says current laws may be giving manufacturers of biologic drugs, like antibodies and flu vaccines, too much in the way of legal protections before copycat ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...