Labeling is based on the agency's thorough analysis of the new drug application (NDA) or biological license application. The labeling, or prescribing information, is thus subject to FDA ...

On-going Phase 2b clinical trial (ELPIS II) deemed pivotal and, if positive, acceptable for Biological License Application (BLA) submission for potential full traditional approval ・Alignment with FDA ...

It originally intended to apply for a biological license application (BLA) on a rolling basis, but the FDA is requesting details about its planned commercial manufacturing sites. Dan Rosenblum ...

And really, just very simply, the major difference between an EUA for a vaccine and a biological license application is the amount and the complexity in the manufacturing data that we would need ...

This remains an open question. Drug maker Eisai has proposed to the FDA, in a supplemental biological license application, that patients stay on past 18 months and switch to half as frequent a dose ...

External feeds included FDA warning letters, biological license applications (BLA) review reports, white papers, and industry benchmark repositories. The company relied on NLP to structure and ...

The U.S. Food and Drug Administration (FDA) has approved two Octapharma supplements to Biological License Applications, strengthening the company's pediatric critical care product portfolio.

Wa'el Hashad Wa'el Hashad, CEO, Longeveron On-going Phase 2b clinical trial (ELPIS II) deemed pivotal and, if positive, acceptable for Biological License Application (BLA) submission for potential ...

Researchers have developed a new biological sensing method that can detect substances at the zeptomolar level – an ...