Regulatory Approval

New data reveals Mapi Pharma's long-acting GA Depot stabilizes disability in both relapsing and progressive MS, poised for a 2027 European launch.

Rapid Medical's new TIGERTRIEVER 25 gains FDA clearance, offering doctors unprecedented real-time control to remove large, complex clots in stroke patients.

An FDA-approved system lets surgeons see residual cancer in real-time during lumpectomies, offering new hope for avoiding the dreaded second surgery.

A new AI platform from ThinkTrends is revolutionizing FDA adverse event reporting, promising $120M in savings and dramatically faster public health insights.

A groundbreaking technology in China is set to revolutionize drug development by revealing atomic structures from previously unseeable nanocrystals.

A new oral therapy shows a 76% response rate in a hard-to-treat lung cancer, offering a powerful new first-line option for patients with this rare disease.

A Chinese biotech has won a key approval for a novel antibody designed to fight deadly leukemias with enhanced safety, marking a new frontier in cancer care.

A new partnership integrates expert rater training with eCOA tech, aiming to reduce costly data errors and accelerate development of new neurological drugs.

Investors eye BioCryst's May 6th report for insights into ORLADEYO's growth, a pivotal acquisition, and its strategy in the competitive rare disease market.

A first-in-class AI software, neuropacs™, gains FDA clearance, promising to help doctors differentiate complex Parkinsonian syndromes with high accuracy.

As millions drive on common medications, a leading expert joins a national panel to address the silent, growing crisis on America's roadways.

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 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.