Regulatory Science

The Calgary biotech aims to file a Clinical Trial Application in Canada to accelerate data generation for its planned FDA NDA submission for XORLO.

New billing codes active from 1 October 2026 streamline hospital reimbursement for QUELIMMUNE and could accelerate adoption in paediatric AKI.

Milestone Pharmaceuticals has expanded its ReVeRA-301 Phase 3 trial to Europe, enrolling the first patient through the Dutch WCN cardiovascular network.

Claris Biotherapeutics presented proof-of-concept data showing CSB-001 improved visual acuity in LSCD patients, with pivotal studies planned for 2027.

Phase 1 data showed topical sildenafil delivered 187-fold lower peak plasma concentrations than oral dosing, supporting FSAD programme advancement.

A University of Manchester-led consortium has published a framework for using computer-simulated patients to support medical device regulatory decisions.

Agomab's ontunisertib Phase 2a extension data in fibrostenosing Crohn's disease will be presented orally at UEG Week as the company readies its Phase

Rua Bioscience will distribute PharmAla's GMP-grade LaNeo MDMA to authorised New Zealand psychiatrists following Medsafe's September approval for PTSD treatment.

Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due

The Virginia biotech secured a Project BioShield award to advance its pralidoxime auto-injector through FDA approval and initial stockpile procurement.

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.

The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.

A Delaware district court found two claims of United Therapeutics' '327 patent valid and infringed, putting YUTREPIA's PH-ILD label at risk.

New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.

New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing

The EMA has begun its centralised review of lorecivivint, a small-molecule CLK/DYRK inhibitor Biosplice positions as a potential first disease-modifying therapy for

The EMA has accepted PolyPid's marketing authorisation application for D-PLEX100, which also faces an FDA PDUFA date of 28 November 2026.

PolarityBio's pivotal COVER DFUS II trial results will be presented on 16 October, ahead of the FDA's March 2027 PDUFA date for SkinTE.

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with

Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.