Regulatory Science

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.

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

EyePoint said its DURAVYU Phase 3 wet AMD trials remain on track for topline data from mid-2026, backed by $223m in cash extending into

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

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

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

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.

The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.

Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.

Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.

The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.

The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.

UroGen posted $29.2m in ZUSDURI sales in Q1 2026, up 109% quarter-on-quarter, as a permanent J Code unlocked broader reimbursement access.