Novo Nordisk is using its ticket for an extra-speedy regulatory review granted through the FDA’s Commissioner’s National ...

Novo Nordisk NVO announced that it has submitted a regulatory filing seeking label expansion for a higher dose of its ...

Through the FDA’s priority voucher program, Novo Nordisk said Nov. 26 it has filed an application seeking approval of its Wegovy 7.2 milligram injection.  Wegovy (semaglutide) is currently approved in ...

Today, Novo Nordisk announced the submission of a sNDA to the U.S. Food and Drug Administration (FDA) for a higher dose of ...

Novo Nordisk's 7.2 mg Wegovy injectable aims to enhance chronic weight management in adults with obesity, using an expedited ...

Novo Nordisk files for FDA review of its higher-dose Wegovy after 72-week data show stronger weight loss than the current 2.4 mg option.

Novo Nordisk (NVO) announced Friday that the U.S. Food and Drug Administration (FDA) accepted its marketing application for an oral formulation of its weight loss therapy Wegovy (semaglutide) for ...

Danish drugmaker Novo Nordisk (NOV: N) has asked the US Food and Drug Administration regulator to assess a stronger 7.2 mg ...

Novo Nordisk A/S’ (NYSE:NVO) Canada unit on Thursday announced that Health Canada has accepted for review, under the Priority Review policy, its supplemental new drug submission (sNDS) for semaglutide ...

Novo Nordisk A/S announced its Q1 earnings today, blaming a slight revenue miss on sales of compounded semaglutide. Q1 2025 earnings showed revenue of ~$11.9bn, operating profit of $5.9bn, with ...

The Food and Drug Administration is set to treat the application under its priority program to accelerate the review of ...