Regulation

Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.

Belgian particle accelerator firm IBA will supply two Proteus ONE compact systems to IPO-Porto, establishing the country's first proton therapy facility by 2029.

The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod

Roche's Krascendo 1 study showed divarasib improved both progression-free and overall survival versus sotorasib or adagrasib in previously treated KRAS G12C lung cancer

Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.

Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.

Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.

Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.

Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.

Week 104 data from the ApproaCH trial show tibial-femoral angle continued improving in children with achondroplasia, with greater gains in those with preexisting leg

The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.

Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.

The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.

Atea has fully enrolled its 880-patient global HCV trial, with topline data from the head-to-head DAA study expected around year-end 2026.

The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.

The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.

LENZ Therapeutics has licensed VIZZ to Australia's largest pharma distributor, marking its fifth international partnership for the FDA-approved presbyopia eye drop.