FDA Approval

With a promising non-opioid drug and new leadership known for major deals, Persica Pharmaceuticals is poised to revolutionize back pain treatment.

RenovoRx sets a key update call, juggling early RenovoCath device sales with its pivotal Phase III pancreatic cancer trial, a beacon for patients.

IntraBio's landmark FDA submission for levacetylleucine offers the first glimmer of an approved therapy for the devastating rare disease Ataxia-Telangiectasia.

The National Bleeding Disorders Foundation taps celebrity power for a live event, aiming to spotlight underdiagnosed conditions and transform advocacy.

Biotech firm Humacyte raises $20M to accelerate sales of its FDA-approved Symvess® and fund crucial trials for new hemodialysis applications.

A new biotech spins out with a novel drug class aiming to provide healthier, more durable weight loss and combat cancer-related wasting syndrome.

As its new obesity drug enters a key trial, Biohaven bets on a novel approach: reducing fat while preserving precious muscle mass. Can it redefine weight loss?

With new execs from Grail and Eli Lilly, ClearNote Health signals a major push to get its AI-powered cancer detection tests through trials and into the market.

After regaining Nasdaq compliance, Incannex Healthcare is leveraging its $75M war chest to advance novel treatments for sleep apnea and anxiety.

Galectin Therapeutics adds legendary neurosurgeon Dr. Henry Brem to its board, a strategic move to leverage his drug development expertise for its lead liver drug.

San Diego biotech elevates key execs as it advances its inflammation pipeline, backed by Sanofi and Lilly, into a competitive and high-stakes market.

Nasus Pharma's NS002 nasal spray reached critical therapeutic levels in half the time of EpiPen, heralding a potential new era for anaphylaxis treatment.

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.