Regulatory Science

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

Zentalis Pharmaceuticals has opened enrolment in its confirmatory ASPENOVA Phase 3 trial of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer.

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

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

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.

The French ophthalmology biotech doubled revenue to €16.8m in 2025 and expects to file its glaucoma candidate NCX 470 with the FDA by summer

The Bedford-based biotech has opened a three-year extension study for AXPAXLI, its long-acting intravitreal hydrogel, aiming to demonstrate disease-modifying benefit in

OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the

Quoin Pharmaceuticals is launching investigator-led trials of its topical rapamycin in three rare skin diseases and plans a first IND filing by Q3 2026.

Eight patients are now enrolled in the RENEW study of inhaled peptide LTI-03, with sites active in the US, Australia, and Poland.

The Swiss rare-disease pharma is putting the former Idorsia CEO forward as an independent director at its 26 May annual general meeting.

Teva will pay $700m upfront for Emalex and its NDA-ready D1 receptor antagonist ecopipam, targeting paediatric Tourette syndrome.

Tonix plans an adaptive Phase 2 field study of its anti-OspA monoclonal antibody in 2027, targeting a prevention gap with no approved U.S