Regulatory Approval

An ultra-rare disease affects thousands, but few are diagnosed. Now, a new alliance of industry and advocates is racing to solve the diagnostic puzzle.

With backing from Eli Lilly, Cabaletta Bio's $150M financing will accelerate its potentially curative cell therapies for autoimmune diseases.

Ncontracts' new Nquiry platform combines 17 years of data with human experts, promising financial firms fast, defensible answers in a complex regulatory world.

A new company emerges from Purdue Pharma's bankruptcy, owned by a non-profit and tasked with fighting the very opioid crisis its predecessor fueled.

Pivotal trial results for a 3D-printed surgical guide show a dramatic drop in follow-up surgeries, heralding a new era of precision for patients.

Diakonos Oncology's personalized therapy, DOC1021, reports impressive survival data in early trials for glioblastoma and pancreatic cancer.

PVP Labs' new drug offers potent pain relief without addiction risk. A landmark DEA ruling clears it as a non-controlled substance, set to reshape medicine.

Swiss medtech firm CorFlow is tackling a major post-heart attack complication with two pivotal trials, aiming to create a new standard of care.

South Korea approves its first homegrown CAR-T therapy, a landmark achievement offering new hope for lymphoma patients with impressive response rates.

New Phase III data shows a dual-action drug delivers significant weight loss while targeting liver health, positioning it as a major new player in the market.

As AI accelerates drug approvals, a new bottleneck emerges. Firms like Totaligent are betting on the infrastructure needed to get therapies to patients.

A new device gets the CE Mark to modernize a 60-year-old cardiac test, promising clearer, faster diagnosis of shunts linked to stroke in millions.

A new stem cell therapy promises a one-time cure for hemophilia A, and the FDA is clearing the path. Could lifelong, costly infusions become a memory?

A novel, FDA-cleared wound therapy is rolling out to military and veteran hospitals, aiming to rewrite the rules of healing for the most complex injuries.

With a fourfold revenue jump, China's Yangtze River Pharmaceutical Group isn't just selling drugs; it's exporting a new model of global trust and quality.

A Cairo hospital's innovative model earns global praise, using revenue from international patients to provide free, world-class cancer care for children.

Henlius and Organon's POHERDY gains EC approval, set to expand access and lower costs for a critical breast cancer therapy across the European Union.

Cordis launches the first sirolimus-eluting balloon for peripheral artery disease in Japan, backed by strong 3-year clinical data showing durable results.

BRC Therapeutics gets the FDA green light for BRC-002, a novel cannabinoid drug for CRPS, a severe pain condition with no approved US treatments.

With gonorrhea becoming increasingly resistant to antibiotics, a new $2.6M grant fuels the development of a promising preventative vaccine platform.