Regulatory Approval

PathAI's PathAssist Derm receives FDA Breakthrough designation, promising to enhance accuracy and speed in diagnosing the most common cancer in the U.S.

With its pivotal trial fully enrolled, Liberate Medical’s VentFree device aims to shorten ICU stays, reduce complications, and cut healthcare costs.

Amid a strategic overhaul, Hepion Pharmaceuticals is licensing a novel RNA-based liquid biopsy, aiming to transform early liver cancer detection.

Aptera Motors built its first validation vehicle, a key step toward delivering its ultra-efficient solar EV to nearly 50,000 reservation holders.

A novel inhaled RNA therapy for a specific group of cystic fibrosis patients gains EMA fast-track status, promising accelerated access to new treatment.

A novel CRISPR-based therapy safely targets deadly E. coli in the gut, showing promise in the fight against antibiotic resistance and for protecting cancer patients.

With soaring revenue and new EU approval, Senseonics is taking control of its sales, but rising costs raise questions about its path to profitability.

A potential first-in-class therapy for two untreatable neurological diseases, co-discovered by AI and robotics, has begun human testing in a major milestone.

A promising oral therapy for Huntington's disease has been deemed eligible for accelerated review in Australia, offering new hope for a breakthrough.

A next-gen drug for chronic hives shows superior, faster results than the long-standing standard of care, heralding a potential shift in allergy treatment.

UroGen's new bladder cancer drug sees rapid uptake post-reimbursement code, but a $153M loss and fresh debt highlight its high-stakes growth strategy.

Lynk Pharmaceuticals reports its oral drug zemprocitinib met all goals in a late-stage study for atopic dermatitis, offering rapid itch relief and a strong safety profile.

With positive Phase 3 data for its first-in-class Stargardt disease drug and a massive new financing round, Belite Bio pivots toward commercialization.

The FDA has greenlit Ascendis Pharma's once-weekly YUVIWEL for achondroplasia, a major step for patients that also carries significant business implications.

A new partnership is building an ultra-low temp supply chain, paving the way for the first off-the-shelf stem cell therapies for pets with chronic disease.

As Canada prepares for generic Semaglutide, U.S. patients look north for relief from soaring drug costs, navigating a complex web of savings and risks.

A new emergency epilepsy medication for children is now available, offering a faster, easier-to-use option for caregivers to stop prolonged seizures.

A new oral therapy, mavorixafor, receives a key recommendation in Europe, offering a beacon of hope for patients with a debilitating ultra-rare immune disorder.

A high-stakes legal battle unfolds as Xeris sues to block generic versions of its blockbuster Cushing's syndrome drug, Recorlev, until 2040.

GEMMABio has dosed the first infant in a trial for its next-gen SMA1 gene therapy, a new approach designed to improve safety and global access.