Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.

ACI-19764 was safe and well tolerated across dose cohorts, with brain penetration confirmed and a therapeutic dose expected at 10mg once daily.

The global HIV trials network is testing a common osteoporosis drug as a latency-reversing agent in a 30-person randomised, placebo-controlled study.

Vascudyne's acellular tissue-engineered vessel maintained full patency for 18 months in a large-animal CABG model, with anticoagulation stopped at six months.

The European Commission has approved the bispecific-antibody doublet for relapsed/refractory myeloma from second line, backed by Phase 3 survival data.

The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.

Humacyte's peer-reviewed Phase 3 data show its bioengineered vessel outperformed standard fistulas in women and obese or diabetic men on haemodialysis.

A 350-patient prospective study found the handheld 6-lead ECG device detected arrhythmias in 14.9% of patients versus 7.7% for standard ambulatory

The Austin-based biotech said the designation supports its inhaled Caveolin-1 peptide, with Phase 2 interim data expected in the second half of 2026.

Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.

The FDA has accepted Teva's NDA for ecopipam with a PDUFA date in Q1 2027, potentially the first new Tourette's therapy in over

VarmX has begun enrolling patients in EquilibriX-S, its pivotal Phase 3 study of VMX-C001 for urgent surgery in patients on Factor Xa inhibitors.