FDA Approval

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?

Praxis Precision Medicines secures a clear path to market for its rare epilepsy drug, blending genetic science with a savvy regulatory strategy.

With leadership buying shares and promising trial data for its novel cancer drug, MAIA Biotechnology is sending strong signals to investors. What's next?

A once-failed class of weight-loss drugs is back with a new design. Corbus Pharma's early data suggests it may have solved the safety puzzle.

Rezolute's stock plummets after its lead drug fails a key trial, raising questions about its future and highlighting the brutal realities of biotech.

With its pivotal trial fully enrolled, IDEAYA Biosciences is on track for a 2026 FDA filing for a new treatment in a rare, deadly eye cancer.

BridgeBio Oncology's new drug candidate BBO-10203 could redefine cancer therapy by avoiding a key toxicity, unlocking a vast market.

Promising data for NuCana's NUC-7738 offers hope for tough-to-treat melanoma, but the biotech's financial health presents a critical hurdle.

A Chinese biotech is pioneering next-gen cancer drugs that promise higher precision and fewer side effects. Is this the future of oncology treatment?

With validated Phase 1b data, ONL Therapeutics' novel drug aims to protect vision cells, not just slow disease, in a challenge to current GA therapies.

A South Korean biotech's novel antibody, now named rapaprutug, could shift the paradigm for pulmonary arterial hypertension by targeting its root causes.

John Crowley, who fought to save his own children, will now shape the future of medicine as he headlines the landmark 2026 MDA conference.

Newron launches a pivotal US trial for its novel schizophrenia drug, evenamide, aiming to help millions who don't respond to current treatments.

New 48-month data for Xenon's azetukalner shows remarkable efficacy, but its real strategy to tackle the total burden of epilepsy may be the bigger story.

After its RELYVRIO setback, Amylyx's next-gen ALS drug AMX0114 clears a key safety hurdle. Is this the strategic pivot investors have been waiting for?

Promising long-term data and key regulatory wins position Wugen's allogeneic therapy to disrupt the challenging T-cell cancer treatment landscape.

With a clear FDA path for its breakthrough drug, Praxis is set to disrupt the stagnant, multi-billion-dollar essential tremor market.