Regulatory Approval

Phase 3 data shows GTx-104 reduces key risks and improves outcomes for aSAH patients, positioning it as a potential new standard of care ahead of an FDA decision.

A new partnership aims to solve a critical challenge for advanced nuclear power, developing a sensor for real-time monitoring inside molten salt reactors.

A new, non-invasive urine test from TOBY, Inc. has received FDA Breakthrough status, challenging blood-based rivals and promising a new era of accessible cancer detection.

A Yale spinout's AI-powered EEG platform promises to prevent birth injuries and cut C-sections by monitoring the fetal brain, not just heart rate.

Taiwanese biotech GlycoNex will begin human trials for GNX1021, a novel ADC that targets cancer's unique sugar coating to fight GI tumors.

Renaissance Pharma's Daretabart gains FDA support for high-risk neuroblastoma, accelerating its journey to patients and offering new hope against this rare disease.

Nutraville's new brain supplement CogniSurge touts a 'glycocalyx' fix. We examine the science, the sales pitch, and what consumers should know.

Replimune halts a promising cancer therapy and cuts jobs after a stunning FDA rejection, citing a 'failed' system and inconsistent regulatory process.

With late-stage trials for two common eye conditions affecting millions, Cloudbreak Pharma is advancing novel drops where no approved drugs exist.

Positive Phase 1b data for two novel drugs suggests a long-acting, once-monthly oral therapy for recurrent genital herpes may be on the horizon.

New Medicare billing codes for the biosimilar Tyenne are now in effect, simplifying reimbursement and aiming to improve access for severe COVID-19 patients.

A new maternal blood test claims over 97% accuracy in predicting autism risk, offering hope for early intervention while igniting a fierce ethical debate.

Treating over 100,000 patients in two years, a novel gel therapy is leading a paradigm shift in interventional dry eye management. Here's how.

In a novel proposal, IKE Tech asks the FDA to regulate its AI-powered compliance software, aiming to curb youth vaping with biometric and blockchain tech.

OncoC4 begins a landmark trial for ONC-841, a drug targeting immune cells in the brain, offering a new front in the fight against Alzheimer's disease.

Aptar Digital Health and Enable Injections are pairing the enFuse® wearable injector with a new digital app to transform self-care for chronic diseases.

With its lead drug in Phase 3 and a strong Biogen partnership, Stoke Therapeutics prepares to update investors on its disease-modifying Dravet syndrome therapy.

CorTec's brain-computer interface gets FDA Breakthrough status, offering new hope for restoring movement in millions of chronic stroke survivors.

After three rejections, Outlook Therapeutics escalates its fight for US approval of a key wet AMD drug, already sold in Europe. Will the FDA bend?

A new minimally invasive stent for complex aortic arch disease receives FDA approval, offering hope to high-risk patients previously deemed untreatable.