CDER's Experience: What We Have Learned from The Pediatric Initiative

Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.

Akeso won NMPA priority review for ivonescimab plus chemotherapy in first-line biliary tract cancer after a phase 3 win over durvalumab plus chemo.

VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.

UCB will use Cradle’s AI-driven protein design platform in selected discovery projects, from hit generation through preclinical readiness, expanding its digital antibody engineering program.

Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.

Matt Trupo, Richard Jaenisch, and Brian Drapeau explore how AI advances biological insights, drug-target discovery, and supply chains.

As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.

Aldevron and IDT added PE Ultra prime editor mRNA and 6 ABE8e base editor mRNAs to help researchers edit DNA without double-strand breaks.