Regulation

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA

The deal gives Crystal Crop exclusive India rights to Cibus gene-editing technology targeting higher mustard yields across 8.5 million hectares.

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with

Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.

The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.

The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.

The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.

The Illinois-based digital health company says its marketplace lists over 7.5 million US providers with CMS pricing and quality data.

Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.

A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.

Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.

Nanobiotix posted H1 2026 results showing encouraging NBTXR3 response rates in lung and head and neck cancer trials, backed by a freshly raised €86 million.

Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.

Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no

aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.

IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its

MediciNova has finished the double-blind portion of its 234-patient Phase 2b/3 ALS trial and expects topline results by end of 2026.

China's CDE has granted Breakthrough Therapy Designation to NXP200, a brain-penetrant BRAF inhibitor, for recurrent BRAF V600-mutant high-grade glioma.

The New York BCI company raised an oversubscribed round co-led by Pershing Square, bringing total funding to $430m since its 2021 founding.

The Cambridge biotech's in vivo Prime Editor targets the root genetic cause of alpha-1 antitrypsin deficiency, with first-in-human data expected in