Regulation

NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.

Pacira BioSciences has licensed its liposomal bupivacaine analgesic to Italian firm Molteni Farmaceutici, targeting first commercial sales in Europe by 2027.

Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening

Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May

Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.

A University of Manchester-led consortium has published a framework for using computer-simulated patients to support medical device regulatory decisions.

Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC

Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.

Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due

Rua Bioscience will distribute PharmAla's GMP-grade LaNeo MDMA to authorised New Zealand psychiatrists following Medsafe's September approval for PTSD treatment.

The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.

argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.

The Virginia biotech secured a Project BioShield award to advance its pralidoxime auto-injector through FDA approval and initial stockpile procurement.

Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.

TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.

The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin

The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.

BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.