Clinical Trials

SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.

Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.

ADARx Pharmaceuticals has secured Fast Track designation for its siRNA candidate onvuzosiran, now in Phase 3 trials for HAE prophylaxis.

Biomea Fusion has fully enrolled its Phase II trial of oral menin inhibitor icovamenib in insulin-deficient type 2 diabetes, with topline data expected in

The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.

Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.

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.

Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.

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.

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.

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