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 Voucher Program.

Novo Nordisk invests €432M ($506M) in Athlone, Ireland to boost oral glucagon-like peptide-1 manufacturing capacity for global markets by 2028.

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.

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 ...

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

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

In response to Marty Makary warning the US may lose the early‑stage drug development lead to China, Brian Scanlan says speed, ...