FDA Approval

The biopharma firm touts transformative drug data ahead, but with cash for only month-to-month operations, its future hangs by a precarious thread.

A new, imageable liver cancer therapy is one step closer to patients, thanks to a strategic partnership securing a vital US-based medical isotope supply.

A new Phase 2 trial for an oral pill offers hope for patients with M. abscessus lung disease, a severe infection with no approved treatments.

The biotech firm's oversubscribed funding round will accelerate its universal flu shot and a diverse pipeline targeting cancer, malaria, and Alzheimer's.

An amended deal with Tasly positions AP Biosciences to license its innovative bispecific cancer therapy to global pharma giants, targeting a lucrative market.

Neumora reveals promising data for Alzheimer's and schizophrenia drugs, but a delay in its obesity program highlights the high-stakes world of biotech.

NUCOT celebrates patients thriving 25+ years post-transplant, setting new global benchmarks in survival rates through advanced care and resilience.

Navigator Medicines pushes two novel bispecific antibodies for Hidradenitis Suppurativa, promising better efficacy and patient-friendly dosing.

New data shows Dizal's ZEGFROVY achieved an 81.3% response rate in a lung cancer subgroup with limited options, signaling a potential new first-line standard.

With a fresh Nasdaq listing and $57.2M in funding, Satellos is advancing a novel muscle-regenerating drug for Duchenne into pivotal pediatric trials.

Agenus prepares a crucial update on its BOT+BAL immunotherapy, a potential breakthrough for cancers resistant to current treatments. What will they reveal?

Tanabe Pharma Canada's 'Letters to ALS' offers a raw, intimate look into the fight against the disease, strengthening community bonds through shared stories.

A new lithium formula boosts brain delivery in a key trial, offering hope for safer, more effective treatments for Alzheimer's, bipolar disorder, and more.

A new RNA drug shows promise by reducing harmful belly fat while preserving muscle, but modest overall weight loss in early trials spooks investors.

Aerin Medical's milestone highlights a major shift toward minimally invasive, in-office treatments for chronic nasal issues, moving beyond traditional surgery.

Swedish biotech VERIGRAFT begins a pivotal trial for a personalized, lab-grown vein, offering hope for a true cure for millions with chronic venous insufficiency.

With new financing from Avenue Capital, Turn Therapeutics bets big on its novel skin therapy, GX-03, to tackle multi-billion dollar dermatology markets.

Sydnexis's eye drop trial shows high efficacy in children 3-12, positioning it as a potential first-of-its-kind FDA-approved drug for myopia.

With key trial enrollment complete, Pyxis Oncology refines its cancer drug MICVO for safety and prepares for pivotal data under a new, seasoned CEO.

Interna Therapeutics, Oxford, and the Gates Foundation team up on a novel intranasal siRNA spray to prevent COVID, tested in a human challenge trial.