Regulatory Approval

A groundbreaking Duke trial combines a novel device to lure cancer cells with targeted immunotherapy, offering real-time tracking and new hope for patients.

With its first drug for a rare disease now on the market, Stealth BioTherapeutics bets its future on a deep pipeline targeting mitochondrial dysfunction.

Health Canada greenlights an 8-week pill for acute HCV, a move experts say is a game-changer in the race to eradicate the virus by 2030.

With stunning clinical data for its miv-cel therapy, Kyverna is set to outline a new era for autoimmune treatment at the J.P. Morgan conference.

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.

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.

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

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.

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.