Regulatory Approval

ProRx Pharma touts a major expansion to meet drug demand, but recent FDA warnings and massive recalls raise serious questions about its quality and safety.

AI promises to transform drug discovery, but billions in investment are at risk. A new report reveals why the real bottleneck isn't tech, but data itself.

With a new legal chief experienced in FDA clearance, Formedics signals an aggressive push to navigate regulatory hurdles and dominate HCP engagement.

Biotech firm BiomEdit has secured patents for a novel biologic that uses engineered probiotics to fight a costly poultry disease, paving the way for antibiotic-free farming.

A new liquid biopsy using viral DNA gets FDA fast-track status, promising to detect liver cancer recurrence more than five months earlier than imaging scans.

A UK biotech's Rincell-1 therapy enters human trials, aiming to regenerate auditory nerves and restore hearing where current technology falls short.

Atsena Therapeutics gets the green light for the final trial phase of a promising gene therapy, offering the first real hope for patients with X-linked retinoschisis.

A new partnership will embed sensors in spinal implants, aiming to solve high patient dissatisfaction rates and disrupt a multi-billion dollar market.

After securing a key CE Mark, OrthAlign is set to challenge Europe's orthopedic market with its capital-free, handheld surgical navigation technology.

A breakthrough drug for pediatric Hunter syndrome, AVLAYAH™, is now accessible via home infusion through an exclusive Orsini and Denali partnership.

A groundbreaking knee implant offers Hoosiers a new joint-preserving option, bridging the gap between conservative care and total knee replacement.

The ACORYS® system offers a non-invasive, real-time, four-chamber heart view, promising to revolutionize arrhythmia treatment and challenge market leaders.

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 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.

With 464 billboards and hyper-local wit, Blockchain.com is betting on British identity to take crypto from niche tech to a household name.

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.