Zealand Pharma's GLP-2 drug candidate fails to gain FDA approval due to request for additional trial to confirm efficacy and safety.

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

At initiation of parenteral prostacyclin therapy, 62% of patients had intermediate-high COMPERA 2.0 risk status, whereas at ...

Copenhagen, Denmark Monday, December 23, 2024, 12:00 Hrs [IST] ...

In its complete response letter, the FDA stated that Zealand's submission lacked sufficient evidence to demonstrate the ...

Attendance Allowance is being paid to people over the State Pension age with a long-term health condition, disability, or ...

Zealand Pharma (ZLDPF) said the FDA has declined to approve its drug glepaglutide for the treatment of short bowel syndrome, citing the need for more data. Read more here.

The FDA has denied Zealand Pharma’s approval bid for glepaglutide—a possible challenger to Takeda’s Gattex—in short bowel ...

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

No. 51 / 2024 U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for ...

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

However, in some premature babies (babies born before 37 weeks of pregnancy), the ductus arteriosus stays open (which is called patent). This means extra blood may flow into the lungs and cause ...