Regulation

The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.

Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.

The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.

Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.

Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax

PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.

The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.

The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.

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.

All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an

The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.

The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.

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

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

REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS

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

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.

Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for

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