US FDA declines to approve Zealand Pharma's bowel disease drug
The U.S. Food and Drug Administration has declined to approve Zealand Pharma's bowel disease drug and sought an additional ...
Yahoo Finance1mon
The fundamentals of developing parenteral drug products
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 ...
Cambridge University Press1mon
Outpatient parenteral antimicrobial therapy in pediatrics: the role of antimicrobial stewardship
Daniel J. Trisno [Opens in a new window], This study characterized outpatient parenteral antimicrobial therapy (OPAT) orders and associated antimicrobial stewardship program (ASP) pharmacist ...
Starbucks enhances parenteral leave benefits for retail teams
CEO Brian Niccol said in a note to employees: “Our success starts and ends with our green apron partners. That’s why making ...
Monthly Prescribing Reference2d
FDA Denies Approval of Glepaglutide for Short Bowel Syndrome
The FDA is recommending an additional clinical trial to confirm glepaglutide’s efficacy and safety at the to-be-marketed dose.
Medscape6d
Should Adding Albumin to Parenteral Nutrient Solutions Be Considered an Unsafe Practice?
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 ...
Zealand Pharma says FDA issues CRL for glepaglutide NDA
Zealand Pharma (ZLDPF) announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the company’s New Drug ...
Pharmabiz3d
Zealand Pharma’s NDA for glepaglutide gets US FDA complete response letter for treatment of short bowel syndrome
Copenhagen, Denmark Monday, December 23, 2024, 12:00 Hrs [IST] ...