Biotechnology

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.

A new injectable dye entering Phase 3 trials promises to make lung cancer cells glow, helping surgeons remove tumors more completely and prevent recurrence.

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.

Exiting stealth, PerturbAI releases an 8-million-cell map of gene function in a living brain, aiming to slash the cost and time of creating new drugs.

Backed by dialysis giants DaVita and U.S. Renal Care, a new startup licenses a first-in-class therapy to transform treatment for kidney patients.

BioCardia's FDA milestone for its Helix catheter could unlock a new era of targeted heart therapies, but financial hurdles and clinical questions remain.

A new collaboration aims to predict immunotherapy success by mapping protein interactions, offering hope for personalized non-small cell lung cancer treatment.

A new telehealth model challenges the prescription-first approach, combining GLP-1s with 24/7 clinical support. Is this the future of metabolic health?

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.

Pharma giant AbbVie taps biotech innovator Alloy Therapeutics to build a novel antibody platform, aiming to unlock a new generation of medicines.

The biotech reports promising clinical data for its lead alpha-therapy program and secures funding into late 2027, navigating a high-cost, high-reward path.

In a new partnership, ALS Network and ALS United are seeking innovative ideas to accelerate breakthroughs, offering fresh hope to the ALS community.

A new one-time gene therapy shows it can clear toxic brain plaques in preclinical studies, offering a potential path to halt or even reverse Alzheimer's.

Following a key acquisition, biosolutions giant Novonesis leverages strong investor confidence to secure long-term financing for its strategic market expansion.

San Diego biotech elevates key execs as it advances its inflammation pipeline, backed by Sanofi and Lilly, into a competitive and high-stakes market.

A new compound could make CAR-T cell therapy more durable and less costly, showing promise against both cancer and HIV in groundbreaking new research.

With its lead autoimmune drug nearing FDA review and a new $250M in funding, Zenas BioPharma prepares for a major leap from R&D to market.