FDA Approval

With a promising schizophrenia drug stalled by FDA requirements and finances tight, Reviva Pharmaceuticals' upcoming presentation is more than just a talk.

Diamyd Medical's pivotal Phase 3 trial gets a nine-month acceleration, raising hopes for a new precision therapy that preserves insulin production.

Alvotech and Teva's settlement with Regeneron for an Eylea biosimilar paves the way for a 2026 launch, promising increased competition and lower costs.

A new settlement positions a cost-effective alternative to the blockbuster eye drug Eylea for a 2026 U.S. launch, signaling intense market disruption.

With FDA & EMA alignment, atebimetinib heads to a Phase 3 trial, offering new hope against deadly pancreatic cancer based on promising early survival data.

A key trial update de-risks Tenax Therapeutics' pivotal study for a novel heart failure therapy, boosting confidence in its path to market.

A new study reveals a tissue allograft, AmchoPlast™, triples healing rates for diabetic foot ulcers, offering a major breakthrough for a common complication.

Can-Fite BioPharma eyes key 2026 data readouts for its late-stage oral drugs targeting advanced liver cancer, psoriasis, and other unmet medical needs.

A breakthrough clinical trial and a savvy financial move could net Fractyl Health $18M to advance its novel obesity treatment beyond the GLP-1 boom.

IO Biotech’s cancer vaccine posts impressive 5-year survival data, but a narrow miss in its pivotal trial creates an uncertain path in a competitive market.

Verastem Oncology taps industry heavyweights for its leadership, signaling a bold new strategy to accelerate its cancer pipeline and grow its market share.

Anixa Biosciences now fully controls its breast cancer vaccine after promising Phase 1 data. What does this strategic move mean for investors and medicine?

As Spruce Biosciences preps its rare disease drug for FDA review, the addition of a commercial veteran signals a high-stakes shift from R&D to market.

Quince Therapeutics' Phase 3 trial completion for Ataxia-Telangiectasia offers hope, but the real story is its innovative red blood cell drug delivery platform.

A new drug for a leading cause of blindness missed its primary goal, yet its unique ability to improve vision offers new hope for millions of patients.

A pivotal trial success in lupus for BTK inhibitor orelabrutinib not only offers new hope for patients but also validates Zenas BioPharma's strategy.

Genmab's $8 billion acquisition of Merus isn't just a deal; it's a bold strategy to own its destiny and dominate the future of oncology therapeutics.

Polyrizon's novel hydrogel shows it can stick to nasal tissue longer without slowing drug delivery, a key innovation in the fight against opioid overdose.

New Phase 2 data shows Elicio's off-the-shelf therapy ELI-002 7P induces "antigen spreading," creating a personalized anti-tumor response.

A tech-driven 'anti-CRO' and a clinical accelerator have joined forces. Can their integrated model finally fix the broken drug development pipeline?