Disease

The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.

Humacyte plans a November 2026 supplemental BLA filing to add haemodialysis access as a second approved indication for its bioengineered vessel.

Milestone Pharmaceuticals has enrolled the first patient in ReVeRA-301, a pivotal Phase 3 study of self-administered etripamil nasal spray for atrial fibrillation with

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.

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.

The all-stock deal, backed by a $150m oversubscribed private placement, creates a Nasdaq-listed company targeting the first FDA-approved therapy for CRPS-1.

Early observations from MiNK's randomised Phase 2 in severe hypoxemic pneumonia showed treated patients alive, afebrile and off ventilator support at Day 28.

Pacira BioSciences' intra-articular gene therapy showed durable tolerability and exploratory pain improvements over two years in moderate-to-severe knee osteoarthritis.

Senseonics lifted its full-year 2026 revenue target to $62–66 million after record quarterly revenue and gross margins beat its own guided range.

Aetna has recognised both implant-free MIGS devices as medically necessary for mild-to-moderate open-angle glaucoma, completing major US payer coverage for Sight

Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.

The Tel Aviv-listed biotech secured an oversubscribed PIPE to take its oral PTH(1-34) tablet through a registrational trial and NDA submission.

IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.

Clearmind Medicine's Phase I/II trial of CMND-100 can progress to patient cohorts after its safety board unanimously approved advancement following a clean