Novo Nordisk announced today that Health Canada has issued marketing authorization with conditions [Notice of Compliance with Conditions (NOC/c)] for Wegovy® (semaglutide injection) for the treatment ...

Vanda Pharmaceuticals Inc. (Vanda) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor ...

In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal ...

The U.S. Food and Drug Administration (FDA) recently announced that it may ease the "serious side effects" warning labels on ...

As Eli Lilly and Novo Nordisk scramble to bring an oral glucagon-like peptide 1 (GLP-1) receptor agonist to market for obesity, much smaller potential rival Structure Therapeutics spotlighted positive ...

The clinical trial showed this experimental medication to be much more effective than any existing GLP-1 drug. But that much ...

EMA issues positive opinion on Novo Nordisk's higher-dose Wegovy, supported by strong weight-loss data and ongoing reviews in ...

Zealand Pharma may be gearing up for a high-stakes year of obesity readouts, but the Danish biopharma thinks the brain could hold the key to the company’s long-term success. | Zealand Pharma may be ...

Phoenix NP announced a continued rise in patient satisfaction across Arizona, noting that positive feedback has increased as more women seek safe, FDA-approved GLP-1 weight loss medications through ...

Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental weight‑loss pill, after the company pushed for a faster ...

An expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed seven new medicines for approval this ...

Top FDA officials have internally pushed for a faster review of Eli Lilly’s (LLY) marketing application for its weight loss pill orforglipron. Read more here.