AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.

1. FDA. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. FDA News Release. March 3, 2026.

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

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 ...

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

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

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

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

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

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, ...

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