FDA Approval

New data on an oral Parkinson's drug and major strides in rare disease research signal Lundbeck's deep commitment to tackling complex neurological disorders.

Theriva Biologics pushes its promising cancer virus toward pivotal trials, but an auditor's 'going concern' warning raises questions about its future.

Ratio Therapeutics appoints Dr. Colin Hayward as CMO, a strategic move to advance its sarcoma trial and challenge leaders in the booming radiopharmaceutical market.

A new study validates Noah Medical's robotic bronchoscopy, showing near-perfect accuracy in diagnosing hard-to-reach lung nodules.

With a massive new investment, Vima Therapeutics advances a first-in-class oral drug into Phase 2, offering new hope beyond injections and surgery.

A new study validating patient-reported outcomes in HAE is set to standardize clinical trials, strengthening the case for new oral therapies like deucrictibant.

As evidence for psychedelic therapy mounts, a key advocacy group brings its case to the UN, challenging decades of prohibitive international drug policy.

After its Alzheimer's drug failed amidst controversy, Cassava Sciences rebrands as Filana Therapeutics, betting its future on a rare epilepsy disorder.

A new campaign by Palvella Therapeutics and key partners aims to educate and empower patients with a rare disease, a strategic move ahead of a potential new drug.

Agenus activates a key manufacturing pact with Zydus, scaling production for its promising BOT+BAL cancer therapy ahead of regulatory filings and market launch.

A new drug targeting the root cause of deadly device infections enters a pivotal trial, offering hope to millions and challenging a $20 billion problem.

Eledon's tegoprubart gets Orphan Drug status, signaling a new era for liver transplant patients by potentially replacing toxic, decades-old therapies.

After selling assets and raising cash, Q32 Bio focuses all its resources on bempikibart, a novel drug for hair loss, with pivotal data due in 2026.

A new, highly selective drug for Duchenne muscular dystrophy shows potential to be safer and more effective, targeting both muscle and heart decline.

A new non-thermal ablation technology shows long-term success in shrinking thyroid nodules with high patient satisfaction, potentially disrupting surgical norms.

With one trial halted and another beginning, the company focuses its cash and hopes on BBI-940, a novel drug targeting a fundamental driver of cancer.

Allarity Therapeutics lands a crucial $20M debt deal to push its unique ovarian cancer drug, stenoparib, through late-stage trials and extend its runway to 2028.

After its public debut, BBOT unveils exciting early data from three unique cancer drugs, including a first in pancreatic cancer, backed by a strong cash runway.

NextCure accelerates its high-stakes ovarian cancer drug trial, but with cash dwindling, can it reach the finish line before time runs out?

With a strong cash position, ArriVent pushes its lead lung cancer drug toward a mid-2026 data readout while building a new pipeline in ADCs.