Proteomics-informed, genome-edited CHO design increased productivity up to three-fold and titers two-fold, strengthening CLD for novel biologics and biosimilars. Extended culture robustness was ...

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

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

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

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.

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

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

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

The rapid pace of digitalization has created a skills gap, necessitating that staff with traditional chemistry or biology degrees upskill in the IT sector . BioVectra addresses this by collaborating ...

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, ...