FDA Approval

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

After clearing the EU's rigorous MDR hurdle, P&F's novel heart valve system secures its European future and sets its sights on the lucrative US market.

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.

New data reveals Orca-T cell therapy boosts survival and cuts complications in blood cancer, as the company prepares for a potential FDA approval this year.

New data reveals an AI-powered system can map and guide heart arrhythmia treatment in minutes with zero fluoroscopy, heralding a new era of safety and speed.

Amid financial scrutiny and following a major trial failure, Vistagen's upcoming Q3 update is a critical test for its novel pherine pipeline.

MetaVia's drug vanoglipel gets a major boost from AI modeling, validating its potential to treat complex metabolic diseases like MASH and Type 2 Diabetes.

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

Affinia Therapeutics gets the green light for a human trial of AFTX-201, a one-time therapy for a devastating genetic heart disease, BAG3 DCM.

With crucial data on its novel oral inflammation inhibitor looming, NodThera brings in seasoned leader Geoff McDonough to navigate the path to Phase 3.

A new biotech partnership is accelerating development of a once-daily tablet for hypoparathyroidism, a rare disease currently requiring injections.

New 4-year real-world data shows Zevra's drug stabilizes the rare, fatal 'Childhood Alzheimer's' disease, marking a milestone for patients and families.

Following promising early results, RESTEM's Restem-L cell therapy enters a pivotal Phase 2/3 trial, aiming to transform treatment for IIM patients.

A new FDA-approved device offers a drug-free alternative for severe rheumatoid arthritis. Rush University is the first in Chicago to implant the system.

As X4 Pharmaceuticals preps for a key investor summit, all eyes are on its pivotal trial for chronic neutropenia and the commercial fate of XOLREMDI®.

A new AI-powered blood test from CareDx shows promise in detecting cancer relapse weeks earlier, offering new hope for transplant patients.

A new liquid biopsy more accurately predicts cancer recurrence than standard methods, offering new hope and clarity for patients after surgery.

Corcept Therapeutics' stock plummeted and it now faces legal probes after the FDA rejected its key drug, revealing the company was warned not to apply.

Tonix Pharmaceuticals' newly approved drug, TONMYA, offers a breakthrough for millions, using unique science to combat the chronic pain of fibromyalgia.

A groundbreaking implantable cell therapy shows consistent, positive results for a debilitating complication of Crohn's disease, paving an expedited path to market.