Regulation

The Eindhoven neurotechnology company has performed the first ARC-IM implant in its EIGER feasibility study, which will enrol up to 12 participants across subacute

The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain

Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.

The Milan biotech signed a convertible loan with the EIB, covering half of its €40m plan to reach CE Mark and EU launch for REGENERA

Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.

Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are

China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to

Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA

Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.

Medtronic posted Q1 revenue of $9.8bn, beating its own guidance midpoint, and lifted its full-year organic growth outlook to 7.25–7.75%.

Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.

Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.

The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.

Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.

The REMODEL-1/-2 trials showed remibrutinib significantly reduced relapse rates versus teriflunomide, with disability progression benefits and no liver safety signal.

Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.

Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could

Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.