Regulatory Science

Orchestra BioMed has drawn a scheduled $15m royalty-financing tranche from Ligand, bringing total Ligand capital to $40m to fund two pivotal cardiovascular device trials.

Expanded analysis of 69 nodular BCC patients showed 200µg D-MNA achieving 55% histological clearance at Day 57, prompting FDA end-of-phase talks.

Integra LifeSciences has appointed chairman Stuart Essig as president and CEO, replacing Mojdeh Poul in a permanent leadership change effective 1 May 2026.

KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal

Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.

ESO's 2026 EMS Index, drawing on 17.3 million records, reveals repeat callers and persistent obstetric care gaps as key system pressures.

Alpha Tau Medical's combination therapy abstract has been selected for podium presentation at the AHNS International Conference on Head and Neck Cancer in July.

The Cambridge DDR biotech has appointed a Chief Business Officer, General Counsel, and VP of Regulatory Affairs ahead of a potential US commercialisation push.

Avalyn will show poster data on inhaled pirfenidone nebuliser usability and patient-centred supportive care in pulmonary fibrosis at ATS in Orlando.

BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.

Bioxodes presented final BIRCH trial data at ESOC 2026, showing BIOX-101 reduced haemorrhage volume and edema growth with no mortality in 23 ICH patients.

CDT Equity has filed for PCT patent protection on its myeloperoxidase inhibitor AZD5904 and is now actively seeking an out-licensing partner for late-stage

Phase 2b CLOVER WaM data show 83.6% ORR and 17.8-month median response duration, strengthening the case for accelerated FDA approval.

Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.

ACACIA-HCM met both primary endpoints — symptom burden and exercise capacity — marking the first positive Phase 3 trial in non-obstructive HCM.

CorTec's Brain Interchange device delivered both stroke rehabilitation and thought-based computer control in one patient using identical implanted hardware.

Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.

CELZ reported its cell-free Ultrasome therapy met its primary endpoint in a knee osteoarthritis pilot, with no serious adverse events observed.

Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.

Mesoblast has hit its 300-patient recruitment target for MSB-DR004, with topline data expected mid-2027 ahead of a planned FDA BLA filing.