Disease

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.

Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.

Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to

Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP

Sanofi posted Q2 net sales of €11.6 billion, lifted by Dupixent and pharma launches, and raised its full-year sales growth target to around

TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large

The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.

The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland

Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology

INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.

PharmAla Biotech has out-licensed its lead MDMA-derived candidate to Jupiter Neurosciences for up to US$100 million, retaining all rights outside the United

Idorsia reported CHF 91 million in QUVIVIQ sales for H1 2026 and reaffirmed full-year guidance of CHF 200 million as it prepares to expand

Deramiocel slowed upper limb decline by 54% versus placebo in a Phase 3 trial, with an FDA decision due 22 August 2026.

The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.

A European Urology study of UK registry data found 0.1% prostate cancer-specific mortality and 3% metastatic progression at 10 years for focal HIFU.

The NASDAQ-listed biotech received a "Study May Proceed" letter for its Phase 2b NDA-enabling study of SkinJect in patients with Gorlin Syndrome.

The Cambridge biotech sheds its renal USP30 programme to fund its Phase 1 Parkinson's candidate MTX325, receiving milestones and tiered royalties.

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.

The NASDAQ-listed vector-borne disease specialist has secured exclusive option rights to FSU's castanospermine IP covering four tick-borne indications.