FDA Approval

Vanda Pharmaceuticals' rare disease drug gets a key designation in Japan, unlocking major incentives and promising a new treatment for a severe skin disease.

MBX Biosciences prepares for the Jefferies conference, with investors eyeing updates on its late-stage hypoparathyroidism drug and promising obesity portfolio.

With game-changing Phase III data for iza-bren in breast cancer and a deep pipeline, SystImmune is poised to make a major impact at ASCO 2026.

Caliway Biopharma advances its fat-loss drug, promising objective, MRI-verified results in a market hungry for safer, more reliable aesthetic options.

A $290M war chest fuels a new public biotech aiming to help millions of migraine patients who don't respond to current blockbuster therapies.

SERB Pharma's acquisition of Idefirix® rights offers new hope to thousands of highly sensitized patients previously unable to receive a kidney transplant.

Preclinical data for JUST-AAV shows enhanced brain delivery and reduced side effects, offering new hope for rare neurodegenerative diseases.

New data reveals TARA-002 has a 55% complete response rate at one year for NMIBC, offering a promising, safer alternative to standard care.

A new oral drug for depression shows rapid, robust effects in a key trial, offering hope for millions by targeting a different brain pathway.

As its CFO presents at a top NYC conference, Healios K.K. advances novel stem cell treatments for ARDS, stroke, and cancer into critical global trials.

NFL legend Brett Favre reports gains from an experimental Parkinson's drug, but what does the science say about this potential breakthrough treatment?

With a new CFO known for big-ticket financing and IPO readiness, clinical-stage OnCusp Therapeutics is gearing up for its next major growth spurt.

A $25M payment from partner Chiesi catapults Protalix to a profitable quarter, funding a promising new gout therapy and a broader rare disease strategy.

Response Pharmaceuticals unveils promising data on RDX-002, a first-in-class drug aimed at preventing a severe side effect of essential mental health drugs.

As its oesophageal cancer vaccine enters trials, Infinitopes hires a top CSO with a track record of bringing breakthrough therapies to market.

A renewed alliance aims to break key supply chain bottlenecks in gene therapy, offering developers faster access to critical, regulatory-ready materials.

Actuate Therapeutics gets FDA nod for its oral cancer drug elraglusib, shifting strategy to improve patient outcomes and tackle hard-to-treat tumors.

With two pivotal trial readouts looming and cash projected to last only into Q4, Tvardi Therapeutics faces a make-or-break year for its STAT3 inhibitors.

Facing financial pressures, the biotech divests a key cancer program, repays debt, and now explores all options to maximize value for its remaining pipeline.

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