Regulation

Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.

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.

Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.

Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in

The collaboration brings Wave Neuroscience's FDA-cleared MeRT system onto neurocare's Apollo TMS platform, targeting the 16 million Americans affected by PTSD.

The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.

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.

Firefly Neuroscience will introduce NeuroSigma's Monarch eTNS sleep-worn neurostimulator to its US clinician network as a non-drug ADHD option for children.

The San Francisco AI healthcare company is one of only two prime awardees on the VA's five-year enterprise ambient scribe contract worth up

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