Novo and Lilly contender Zealand Pharma heralds its obesity drug alternative: It's our 'crown jewel'
Danish biotech Zealand Pharma is targeting the "next generation" of weight loss drugs as competitors pile into a market ...
pharmaphorum2d
FDA knocks back Zealand's dasiglucagon once again
Zealand Pharma has suffered another setback in its bid to bring glucagon receptor agonist dasiglucagon for ultra-rare disease ...
FiercePharma2d
Zealand's hypoglycemia drug suffers another FDA rejection tied to CDMO inspection
After third-party manufacturing issues led to a December rejection of Zealand Pharma’s pediatric congenital hyperinsulinism (CHI) candidate, the Danish pharma’s latest snub seems to come down to ti | ...
Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism
No. 48 / 2024 Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism U.S. Food and Drug ...
The Pharma Letter1d
FDA slaps another CRL on Zealand Pharma’s dasiglucagon NDA
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application ...
ENDPOINTS NEWS2d
Zealand Phar­ma hit with sec­ond CRL for glucagon re­cep­tor ag­o­nist
The FDA handed down a second complete response letter to Zealand Pharma for its glucagon receptor agonist in an ultra-rare ...
Zealand, Boehringer win FDA breakthrough status to treat fatty liver
Denmark's Zealand Pharma and German partner Boehringer Ingelheim have won the U.S. Food and Drug Administration's ...
BioSpace2d
Zealand Hit With CRL for Ultrarare Genetic Disease Treatment
The rejection is related to the timing of the FDA’s reinspection of Zealand’s third-party manufacturer, which previously had ...
Zealand Pharma: FDA Issues CRL For Dasiglucagon In Congenital Hyperinsulinism
Zealand Pharma A/S (ZEAL) said that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL for Part 1 of ...
Zealand Pharma A/S (OTCMKTS:ZLDPF) Trading Down 2.3% – Here’s What Happened
Zealand Pharma A/S (OTCMKTS:ZLDPF – Get Free Report) traded down 2.3% during trading on Wednesday . The stock traded as low as $115.00 and last traded at $115.00. 505 shares traded hands during ...
Can this European biotech challenge Eli Lilly in the booming weight-loss market?
Zealand Pharma is working on the next-gen weight-loss treatment. Its Petrelintide showed promising results in a Phase 1b ...