FDA Approval

Aardvark Therapeutics is expanding its Phase 3 trial for a novel Prader-Willi Syndrome drug to include children as young as seven, targeting a key unmet need.

With its lead drug in Phase 3, Celldex will update investors at three major conferences, highlighting its immunology pipeline and financial strategy.

With five conferences in its sights, Voyager Therapeutics is making a major push to win over investors ahead of a pivotal year for its neurological pipeline.

With rapid trial enrollment for a novel drug, Pulmovant offers a potential lifeline for patients with PH-ILD, a condition with few to no options.

Viking Therapeutics' upcoming earnings call is about more than just financials. Investors are focused on key pipeline updates for its obesity and MASH drugs.

Early trial data for ABX1100 reveals a novel approach to reducing muscle damage in Pompe disease, offering hope for less burdensome treatment.

The biotech celebrates its first FDA drug approval, a massive financial boost, and promising new therapies targeting obesity and Alzheimer's disease.

A new drug from Bayer dramatically cuts recurrent stroke risk by 26% without the dangerous bleeding side effects of current therapies, offering hope to millions.

TransCode Therapeutics and Quantum Leap are targeting hidden cancer cells with a novel RNA drug in a pivotal trial that could prevent colorectal cancer relapse.

A simple nasal spray could offer immediate, broad protection against the flu. New landmark studies show how this antibody-based shield could revolutionize prevention.

New preclinical data suggests Arcellx's CAR T therapy may offer a safer profile than rivals, potentially avoiding severe neurological side effects.

As GLP-1 drugs dominate, Veru Inc. advances a novel therapy to combat muscle loss, aiming for a new standard of 'quality' weight loss in older adults.

Beyond Cancer is set to reveal early human trial data for its novel nitric oxide therapy, a move that could expand its parent company into oncology.

An expanded partnership aims to deliver a once-daily oral tablet for hypoparathyroidism, potentially revolutionizing treatment for thousands of patients.

Celcuity prepares for a key fireside chat at Guggenheim's 2026 summit, with investors eyeing crucial updates on its lead cancer drug, gedatolisib.

Final Phase 1b data for Kodiak Sciences' KSI-101 suggests a potential breakthrough for macular edema, a condition lacking dedicated biologic therapies.

Estrella Immunopharma unveils promising Phase 1 data for its next-gen T-cell therapy, but can it overcome a crowded market and its own financial hurdles?

Current blood thinners carry a risky trade-off. A new class of drugs targeting Factor XIa could prevent deadly clots without the dangerous bleeding.

A next-gen immunotherapy enters trials, hoping its safer design can unlock the immune system and form a potent combo against advanced solid tumors.

With a major Phase 3 trial now in Europe, Crystalys Therapeutics aims to fill a critical gap in gout care with a drug already proven in Asian markets.