FDA expanded zongertinib’s accelerated approval to treatment-naïve HER2-mutant advanced NSCLC, contingent on mutation ...

FDA granted Hernexeos accelerated approval for 1st-line HER2-mutant NSCLC after a 44-day review via the National Priority ...

Novo Nordisk invests €432M ($506M) in Athlone, Ireland to boost oral glucagon-like peptide-1 manufacturing capacity for ...

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a ...

As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...

FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

For those monitoring innovation pipelines, patent intelligence is becoming a leading indicator of competitive positioning.

Asahi Kasei acquires Aicuris for €780M ($920M), adding anti-infective assets to its transplant and nephrology specialty ...

Univar Solutions' Ingredients + Specialties division has been appointed as the distributor for Ingredion Pharma Solutions, ...

GSK acquires 35Pharma for $950M. The primary focus is HS235, a selective PH drug reducing bleeding risk with metabolic ...

Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before ...

A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...