Biologics

Vertex Announces FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy

Vertex Pharmaceuticals announced that the FDA has accepted its Biologics License Application for accelerated approval of povetacicept in IgA nephropathy, with a PDUFA target date of November 30, 2026. The filing is supported by positive week 36 interim analysis data.

Biologics and Manufacturing Challenges in Biopharma

As biologics take the lead in biopharma pipelines, manufacturing challenges are hindering new product launches. This article explores the implications for the industry.

IPEC Excipient World Biologics Summit 2026: Recap

The IPEC Excipient World Biologics Summit, a key event for professionals in the pharmaceutical and biologics industries, will take place May 4-6, 2026, in Nashville, TN. This summit focuses on the critical role of excipients in biologics manufacturing.

Innovent Biologics IBI363 Clinical Data to Be Presented at ASCO 2026 Annual Meeting

Innovent Biologics announces new clinical data for IBI363, a PD-1/IL-2α bispecific fusion protein immunotherapy, will be presented at ASCO 2026.

Small Molecule vs Biologics in Oncology: Market Trends & FDA Insights 2024

This article delves into the evolving landscape of oncology treatments, comparing small molecules and biologics, with a focus on market trends and FDA insights for 2024.

Biosimilar Competition Impact: US Biologics Market Analysis 2026

This analysis delves into how biosimilar competition will reshape the US biologics market by 2026, highlighting significant drugs and their therapeutic indications.

EpiBiologics Begins Phase 1 Trial of EPI-326 Bispecific Antibody for EGFR-Driven Cancers

EpiBiologics doses first patient with EPI-326, a tissue-selective bispecific antibody targeting EGFR-driven solid tumors in global Phase 1 study.