Drug Development

With a fortified balance sheet and promising clinical data, Monopar Therapeutics is advancing its lead drug, ALXN1840, toward a pivotal NDA filing.

After its pivotal trial for ersodetug missed its primary endpoint, Rezolute gets a rare nod from the FDA to submit full data, igniting new hope.

New research on ILUMYA, LEQSELVI, and WINLEVI shows sustained efficacy and faster results, aiming to transform treatment for millions of patients.

New 3-year trial data shows UCB's BIMZELX prevents painful flares in most HS patients, highlighting a critical window for early intervention.

The pharma firm hit pause on a crucial reverse stock split needed to keep its Nasdaq listing, citing "timing considerations" and raising investor questions.

A groundbreaking study of 78,000 people shows most with acne and psoriasis manage their conditions alone, outside the clinic. Here's what it means.

A new lithium formula boosts brain delivery in a key trial, offering hope for safer, more effective treatments for Alzheimer's, bipolar disorder, and more.

Weave Bio forms a star-studded advisory board with leaders from Gilead and Takeda to navigate the high-stakes world of AI in drug development.

SciTech's ST-001 overcomes a decades-old barrier for fenretinide, showing promising results for Cutaneous T-Cell Lymphoma patients in early trials.

With new financing from Avenue Capital, Turn Therapeutics bets big on its novel skin therapy, GX-03, to tackle multi-billion dollar dermatology markets.

A new Phase 2 trial is testing an inhaled version of a key IPF drug, aiming to reduce severe side effects and transform treatment for the fatal lung disease.

UK biotech Amphista to showcase its innovative Targeted Glue™ platform at AACR, revealing new data for AML, lung cancer, and mesothelioma therapies.

With fresh funding secured, Dogwood Therapeutics pushes its promising nerve pain drug, Halneuron®, toward a pivotal data readout later this year.

InflaRx announces a late-breaking presentation on its Phase 3 trial for vilobelimab, offering potential new hope for pyoderma gangrenosum patients.

The FDA grants PolyPid a crucial $4.3 million fee waiver for its D-PLEX₁₀₀ drug, freeing up vital cash to accelerate its commercial launch.

Aldeyra Therapeutics' dry eye drug, reproxalap, was rejected by the FDA for a third time, citing inconsistent data and wiping out millions in value.

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

A new collaboration will use Voro's 'masking' technology to create tumor-activated ADCs, aiming to make powerful cancer therapies safer and more effective.

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.

UK biotech Alchemab hires Sanofi's Ulrich Wendt as CBO to forge major pharma deals for its novel AI platform that mines the secrets of human resilience.