Regulatory Approval

Aldeyra Therapeutics' dry eye drug, reproxalap, was rejected by the FDA for a third time, citing inconsistent data and wiping out millions in value.

A simple blood test is revolutionizing Alzheimer's diagnosis. ALZpath's pTau217 antibody is now the industry benchmark, promising earlier detection for millions.

A new compound could make CAR-T cell therapy more durable and less costly, showing promise against both cancer and HIV in groundbreaking new research.

Oaktree Capital will acquire a controlling stake in Atlantic Coast Life, providing a critical lifeline to A-CAP's financially troubled insurance units.

One year post-approval, Neurotech's novel gene therapy implant is transforming patient lives and rewriting the playbook for biotech commercialization.

Theriva Biologics pushes its promising cancer virus toward pivotal trials, but an auditor's 'going concern' warning raises questions about its future.

The precision oncology firm reports a dramatic cut in net loss and a strategic pivot paying off, bolstered by a new U.S. patent for its cancer tech.

First Quantum Minerals divests its Çayeli mine to bolster finances as Turkish conglomerate Cengiz Holding expands its grip on national resources.

The Personalized Health Association launches to modernize U.S. policy, sparking debate over innovation, patient safety, and the future of tailored care.

A new study validating patient-reported outcomes in HAE is set to standardize clinical trials, strengthening the case for new oral therapies like deucrictibant.

With a strong cash position and new leadership, Artiva pivots its AlloNK® cell therapy to autoimmune disease, targeting a pivotal trial for RA in 2026.

Eledon's tegoprubart gets Orphan Drug status, signaling a new era for liver transplant patients by potentially replacing toxic, decades-old therapies.

Edgewise Therapeutics' drug sevasemten shows unprecedented functional stability in Becker muscular dystrophy, a pivotal shift for a disease with no treatments.

ViruSure's new GMP-validated test using Oxford Nanopore sequencing promises to slash drug safety testing times, boosting supply chain resilience.

Michigan-based ELGA CU completes its cross-state purchase of Marine Bank, blending community focus with expanded commercial and consumer services.

Backed by heavy insider investment, the surgical robotics firm aims to disrupt the US and EU markets with its affordable SSi Mantra system.

A new drug, CRS3123, not only cures C. difficile but drastically cuts recurrence rates by preserving the gut microbiome, a major leap over standard care.

Eleven Ohio families won a landmark $2.3M arbitration award after their advisor breached its duty. The case sends a stark warning to the entire industry.

A new surgical robot from Beijing's Healinno Tech uses AI and a high-pressure waterjet to treat prostate issues with unprecedented precision and safety.

Early access programs for a rare blindness therapy in France, Israel, and the US offer hope to patients and provide a crucial financial lifeline for the company.