A target product profile (TPP) is a set of necessary attributes that the final drug product must have for the product to be used. It includes aspects such as pH range, osmolality and API ...

Daniel J. Trisno [Opens in a new window], This study characterized outpatient parenteral antimicrobial therapy (OPAT) orders and associated antimicrobial stewardship program (ASP) pharmacist ...

The U.S. Food and Drug Administration has declined to approve Zealand Pharma's bowel disease drug and sought an additional ...

CEO Brian Niccol said in a note to employees: “Our success starts and ends with our green apron partners. That’s why making ...

Purpose: The technical issues surrounding the use of albumin in parenteral nutrient (PN) solutions are reviewed. Summary: Five criteria have been suggested to determine which compounds are optimal ...

The FDA is recommending an additional clinical trial to confirm glepaglutide’s efficacy and safety at the to-be-marketed dose.

Zealand Pharma (ZLDPF) announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the company’s New Drug ...