Regulatory Science

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn

Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.

The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.

The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.

Nokia's Network as Code platform replaces SMS one-time passcodes for BeeHealthy, a white-label health SaaS serving providers across Europe and the Middle

IBA will co-lead end-of-life and waste-management work in a 91-partner EU initiative targeting PFAS removal from healthcare and pharmaceutical waste

Envetec has named Patrick S. Jones, president of Thermo Fisher's Clinical Diagnostics Division, as an independent director to support its US expansion.

California's public health regulator has approved the Irish cleantech firm's non-thermal GENERATIONS system for biohazardous and sharps waste treatment.

The Pennsylvania-based medtech said the CE Mark opens European commercial sales of its intraoperative 3-in-1 imaging platform, which integrates with its ExcelsiusGPS

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

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

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

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.

Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation

Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.

The FDA agreed on the primary endpoint and placebo-control design for Cadrenal's Phase 3 trial of its 12-LOX inhibitor in heparin-induced

The French-American biotech has hired a 30-year industry veteran to lead operational and commercial readiness as its lanifibranor Phase 3 data approaches.

Palvella Therapeutics has filed its full NDA with the FDA for QTORIN rapamycin gel, targeting a rare condition with no approved treatment options.

The Nasdaq-listed biotech secured IP protection for its cannabinoid agonist's commercial formulation, extending coverage to 2041 across two active Phase 2 studies.