FDA Approval

A novel drug combination shows promising early results for a deadly ovarian cancer, potentially expanding the benefit of immunotherapy to more patients.

With new funding, ImageneBio advances its unique OX40 inhibitor, IMG-007, for eczema and alopecia, but faces a divided Wall Street.

Allogene Therapeutics faces a make-or-break moment as it prepares to unveil crucial trial data for its 'off-the-shelf' cancer therapy, cema-cel.

With the hire of a top scientist, a minority-owned IT firm signals its ambition to tackle complex federal health challenges and compete with industry giants.

A Swiss biotech's novel antibiotic has entered human trials with new funding, offering a fresh hope against the world's most dangerous superbugs.

A single-dose therapy wiped out aggressive glioblastoma tumors in a landmark pre-clinical study, paving the way for human trials in 2026.

A new clinical trial is underway for a next-gen aortic valve, promising a less invasive procedure and improved durability for millions of patients.

With stellar trial data for its cholesterol drug obicetrapib, NewAmsterdam Pharma faces investors as it navigates a competitive market and awaits key results.

Following positive safety data, Phanes Therapeutics expands trials for spevatamig, a first-in-class antibody targeting two cancer pathways at once.

AIRNA has dosed the first patient with AIR-001, an RNA-editing drug that could treat both the lung and liver damage of a devastating genetic disease.

A new trial for advanced liver cancer tests visugromab, a drug aiming to overcome immunotherapy resistance and reverse debilitating cancer-related wasting.

A long-acting ketamine injection shows promise in treating severe depression without the harsh side effects and monitoring, potentially expanding access for millions.

A $10M investment from BVF Partners propels Entera Bio’s revolutionary oral osteoporosis drug into a pivotal Phase 3 trial, a major step for patients.

A novel triple-action topical spray for male pattern baldness enters a pivotal clinical trial, potentially disrupting a multi-billion dollar market.

AskBio completes enrollment for a pivotal Phase 2 trial of a one-time gene therapy, potentially revolutionizing treatment for millions with heart failure.

The biopharma firm touts transformative drug data ahead, but with cash for only month-to-month operations, its future hangs by a precarious thread.

A new, imageable liver cancer therapy is one step closer to patients, thanks to a strategic partnership securing a vital US-based medical isotope supply.

A new Phase 2 trial for an oral pill offers hope for patients with M. abscessus lung disease, a severe infection with no approved treatments.

The biotech firm's oversubscribed funding round will accelerate its universal flu shot and a diverse pipeline targeting cancer, malaria, and Alzheimer's.

An amended deal with Tasly positions AP Biosciences to license its innovative bispecific cancer therapy to global pharma giants, targeting a lucrative market.