Minoryx Therapeutics secures exceptional-circumstances CHMP recommendation for leriglitazone
Leriglitazone wins a positive European opinion for boys with early cerebral adrenoleukodystrophy after a narrower pediatric application.
Pharma & Biotech
Pharma & Biotech
Gilead’s Trodelvy cleared a key EU hurdle, but can it really replace chemotherapy in first-line TNBC?
CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic TNBC, moving Gilead closer to an expanded EU label.
Pharma & Biotech
Laminar Pharma has finished patient follow-up. Now one survival result will decide LAM561’s future
Laminar Pharma completes LAM561 trial follow-up as the glioblastoma study advances toward a pivotal overall survival readout in 2027.
Pharma & Biotech
Europe’s immuno-oncology pipeline has a translation problem. Can SITC’s Lausanne summit fix it?
SITC’s Lausanne summit will connect regulators, biotech and academia to sharpen Europe’s path from immuno-oncology science to clinical trials.
Pharma & Biotech
Affinia Therapeutics advances AFTX-201 gene therapy for BAG3 dilated cardiomyopathy
Affinia Therapeutics gains FDA orphan status for AFTX-201 as the UPBEAT trial tests gene therapy for BAG3 dilated cardiomyopathy.
Pharma & Biotech
Zai Lab’s August 6 earnings could reveal whether its 2026 commercial reset is starting to work
Zai Lab reports Q2 2026 results on August 6 as investors assess revenue pressure, COBENFY and TIVDAK launches, and zoci pipeline progress.
Pharma & Biotech
Nektar Therapeutics starts Phase 3 ZENITH-AD trials of rezpegaldesleukin for atopic dermatitis
Nektar Therapeutics has initiated the first two studies in a 1,530-patient Phase 3 programme evaluating rezpegaldesleukin in adolescents and adults with moderate-to-severe atopic dermatitis, beginning the pivotal test of whether regulatory T-cell stimulation can compete with established eczema biologics and oral medicines. ZENITH AD-1 and ZENITH AD-2 will each enroll approximately 510 patients who have
Pharma & Biotech
Kyowa Kirin wins European Crysvita approval for infants from one month of age
Crysvita wins European Union approval for infants from one month, widening early XLH treatment and strengthening Kyowa Kirin’s rare disease franchise.
Pharma & Biotech
Could Ebglyss challenge Dupixent in younger children? Almirall clears a crucial EMA filing hurdle
Almirall’s Ebglyss paediatric filing enters EMA review, opening a potential path into Europe’s childhood atopic dermatitis market.
Pharma & Biotech
Vanda’s imsidolimab has won a rare European advantage, but one approved rival changes the equation
Vanda’s imsidolimab gains an EMA orphan recommendation for GPP, but approval, differentiation and European access remain ahead.