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

ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia

Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations

Godavari Biorefineries' anti-cancer patent now validated in Spain and UK

Anti-cancer patent now validated in Spain, the UK, and as a Unitary Patent covering multiple EU member states

Teijin Pharma receives approval for additional indication for XEOMIN in Japan

Bachem expands multi-site production capacities to meet rising demand

The Swiss peptide and oligonucleotide manufacturers roll out major investments across site networks in US, UK and Switzerland

Boehringer Ingelheim and Eko Health collaborate to improve heart murmur detection in dogs

The partnership combines Boehringer’s expertise in canine cardiology with Eko’s digital stethoscopes and AI algorithms

Allarity announces enrolment of first patient in phase 2 clinical trial protocol of Stenoparib in advanced ovarian cancer

The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval

Sanofi exercises license extension option to Nurix’s STAT6 program

his is the second license extension of a Nurix autoimmune disease program by Sanofi in the last 90 days