Vasa Therapeutics secures FDA IND clearance to advance VS-041 into clinical trial for HFpEF

IND clearance enables initiation of Phase 1c clinical trial in HFpEF patients with elevated endotrophin levels

Enveric clears FDA feedback milestone, prepares IND submission for EB-003

IND application for EB-003 expected in early 2026

Senhwa Biosciences’ Pidnarulex joins forces with global PD-1 leaders to advance next-gen immunotherapy

This strategic collaboration represents the third clinical trial under Senhwa’s five-year NCI-sponsored cancer research program

GC Biopharma submits IND to begin Phase 3 clinical trial for Barycela in Thailand

FDA approves Coya Therapeutics’ trial of COYA 302 for ALS

As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

SPARC announces submission of IND Application for SBO-154 to USFDA

The IND application supports the next phase of development of SBO-154

Novo Nordisk strikes $1bn deal for Lexicon’s oral obesity drug

Lexicon Pharmaceuticals announces exclusive license agreement with Novo Nordisk for LX9851

AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma

SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3