The US FDA has extended its review of Novo Nordisk's experimental hemophilia A drug due to ongoing remediation work at a manufacturing facility, the Danish drugmaker said on Friday.
Bagsværd, Denmark, 02 October 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has informed Novo that the BLA review of denecimig for the treatment of haemophilia A, with or without inhibitors in adults and children, is still ongoing. The FDA has not communicated a new timeline for expected regulatory action on the BLA.
Eli Lilly and Novo are developing new amylin drugs that serve as another biological lever to pull in treating obesity and diabetes, either as independent treatments or layered on top of existing drugs. A new slate of injections, pills, and combination regimens target the amylin pathway, which involves a hormone released in the pancreas alongside insulin that helps regulate hunger and fullness.
Novo Nordisk (NYSE:NVO) faces further pressure in the obesity-drug market after Eli Lilly and Co (NYSE:LLY) reported promising mid-stage data for an experimental treatment that delivered greater weight loss than tirzepatide alone. EloraTZP, a combination of eloralintide and tirzepatide targeting amylin, glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 pathways, produced ...
A Trump administration rule to cut hospital drug prices for Medicare patients may apply to as few as four drugmakers after exempting companies that signed separate "most favored nation" pricing agreements with the administration, according to the finalized rule.
Patients who switched from weight-loss injections to Novo Nordisk's daily Wegovy pill continued to lose weight, according to data unveiled at a medical meeting on Wednesday, as the Danish drugmaker seeks to defend its lead over US rival Eli Lilly in the market for oral obesity treatments.
People who switched from obesity injections to Novo's new Wegovy pill continued to lose weight after three months, according to an analysis of real-world data the company presented. Patients who switched from either a Wegovy shot or Lilly's Zepbound injection to the Wegovy pill and stayed on treatment for three months lost roughly 4% of their weight on average.
Novo Nordisk said on Tuesday a real-world study found that adults with type 2 diabetes who took an escalated dose of its diabetes drug, Ozempic, had a lower risk of major cardiovascular events compared to those who switched to Eli Lilly's Mounjaro.
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