Regulatory Approval

A tiny implant stimulating the vagus nerve offers new hope for severe RA. A landmark study now validates this bioelectric therapy for patients out of options.

A new therapy claims to reverse cellular aging to cure disease, but its patient-funded trial model sparks a debate on equity and medical ethics.

New AMA codes for PolarityBio's SkinTE signal a strategic step toward commercialization, aiming to ease clinical adoption for chronic wound care.

Weight Watchers now offers the new Wegovy pill, a needle-free option, betting its future on combining powerful GLP-1 drugs with its classic support.

LENZ Therapeutics partners with Lunatus to launch its breakthrough VIZZ™ presbyopia eye drops in the Middle East, targeting a vast, unmet medical need.

With promising 3-year vision data and a manufacturing breakthrough, Lineage is pioneering 'off-the-shelf' cell therapies for blindness, diabetes, and more.

Formerly Cybin, Helus Pharma's Nasdaq launch marks a pivotal shift towards commercializing its breakthrough depression and anxiety drug pipeline.

Gyre Therapeutics secures a pivotal conditional approval pathway in China for its novel liver fibrosis drug, offering hope for millions of hepatitis B patients.

A new drug could redefine life for polycythemia vera patients, replacing frequent, burdensome blood draws with a simple weekly self-injection.

Health Canada has approved JERAYGO, the first new hypertension drug class in 30 years, offering a lifeline to patients with hard-to-treat high blood pressure.

The robotics firm is outsourcing key software development in a strategic move to reduce cash burn and speed its innovative surgical system to market.

Biotech pioneer Dr. Patrick Soon-Shiong is named a top influencer in oncology, boosting ImmunityBio amid strong sales and a promising drug pipeline.

A new partnership with logistics giant Uniphar will bring Zevra's breakthrough NPC therapy, MIPLYFFA, to patients in underserved regions worldwide.

After resolving a key manufacturing issue, Unicycive has resubmitted its kidney drug NDA, offering new hope for dialysis patients with a lower pill burden.

Bluejay Diagnostics can now make 9 million sepsis tests. This manufacturing win is huge, but the real race for FDA approval has only just begun.

Diamyd Medical's pivotal Phase 3 trial gets a nine-month acceleration, raising hopes for a new precision therapy that preserves insulin production.

Mirum raises over a quarter-billion dollars to acquire Bluejay Therapeutics, targeting a high-potential liver disease drug and signaling major growth.

Alvotech and Teva's settlement with Regeneron for an Eylea biosimilar paves the way for a 2026 launch, promising increased competition and lower costs.

A new settlement positions a cost-effective alternative to the blockbuster eye drug Eylea for a 2026 U.S. launch, signaling intense market disruption.

A new oral drug, cadisegliatin, enters a major clinical trial in the UAE, aiming to help Type 2 diabetes patients struggling with insulin therapy.