Drug Application

Iterum Therapeutics secures key Medicare access for its antibiotic ORLYNVAH™, but a costly FDA trial requirement for a new use casts a shadow on its future.

After a major trial failure tanked its stock, Rezolute pins its hopes on a second drug program and a crucial FDA meeting to chart a path forward.

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.

IN8bio promotes Kate Rochlin to President, signaling a strategic push to advance its promising gamma-delta T cell pipeline amid a challenging market.

With a promising spinal cord injury drug nearing late-stage trials, NervGen appoints interim leader Dr. Adam Rogers as permanent CEO to guide the breakthrough.

As HUTCHMED prepares to unveil its 2025 financials, investors weigh a complex picture of global drug success, domestic pressures, and pipeline promise.

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.

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.

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®.

BridGene Biosciences adds Nobel winner Dr. Bruce Beutler to its board, gaining immense credibility for its mission to create drugs for intractable diseases.