FDA Approval

With key clinical data on the horizon for its cancer and ALS drugs, LeonaBio adds deep financial, operational, and strategic expertise to its leadership.

A massive $250M investment could replace a 40-pill daily burden with a single tablet for patients with pancreatic insufficiency, disrupting a market in crisis.

A new drug shows major promise for a painful heart condition, with pivotal study results accepted by a top journal and a final-stage trial speeding ahead.

Sensei Biotherapeutics begins a key trial for PIKTOR, a novel oral therapy aiming to outsmart cancer resistance in patients with advanced breast cancer.

The clinical-stage biotech adds seasoned veterans from Eli Lilly and Iovance to accelerate its promising DNA Damage Response pipeline toward commercialization.

Valitor's VLTR-559 shows superior durability in preclinical data, potentially slashing wet AMD treatment from monthly injections to just two per year.

A new gene therapy has helped completely blind patients with Retinitis Pigmentosa regain light perception, offering hope to millions with inherited blindness.

A new peer-reviewed study shows Glucotrack's fully implantable glucose monitor is accurate for 240 days, a key step towards a 3-year, no-wearable future.

A new imaging agent could slash the years-long diagnostic delay for endometriosis, offering hope to millions of women suffering from the debilitating condition.

Swiss medtech firm CorFlow is tackling a major post-heart attack complication with two pivotal trials, aiming to create a new standard of care.

A novel immunotherapy that freezes and infuses tumors shows an 87% response rate in advanced prostate cancer, aiming to turn local treatment into a systemic attack.

With patient enrollment accelerating for its novel lung fibrosis drug, LTI-03, Rein Therapeutics signals progress in a field desperate for new options.

YPrime's new AI Calculation Engine lets researchers use plain language to build complex trial logic, aiming to slash setup times and boost data accuracy.

A new cell-free therapy, Ultrasome™, shows a 93% response rate in a pilot study, offering a scalable, regenerative solution for millions with knee pain.

Vensica Medical gets FDA clearance for a Phase 2 study of its ultrasound device that delivers botulinum toxin without needles for overactive bladder.

Neurogene bets on a direct-to-brain delivery method for its Rett syndrome gene therapy, arguing the established surgical technique offers superior results.

BRC Therapeutics gets the FDA green light for BRC-002, a novel cannabinoid drug for CRPS, a severe pain condition with no approved US treatments.

As it preps a first-in-human study for a deadly genetic heart disease, Nuevocor brings on gene therapy veteran Dr. Monica Shah to lead the charge.

With gonorrhea becoming increasingly resistant to antibiotics, a new $2.6M grant fuels the development of a promising preventative vaccine platform.

A new non-viral gene therapy targeting iron buildup in the eye has completed its Phase I trial, offering a potential new path for millions with dry AMD.