Regulatory Approval

With FDA Priority Review, Takeda's oveporexton could be the first drug to target the root cause of narcolepsy, offering transformative hope for patients.

Bolstered by a top regulatory expert and unique veterinary data, Vivos Inc. is set to file for human trials of its precision injectable cancer treatment.

In a major market shakeup, Dingdong is selling its China grocery operations to rival Meituan and plans to return the proceeds to shareholders.

Following a landmark FDA approval, IceCure Medical's long-serving CFO is exiting, placing the company at a pivotal financial crossroads for its new treatment.

AB Science's Masivet gets key FDA designation, paving the way for a new targeted cancer therapy for dogs and a major strategic win for the company.

A Chinese biotech's novel nasal spray flu vaccine enters trials. Its unique design could finally make it safe for the elderly and expand global access.

With a promising spinal cord injury drug nearing late-stage trials, NervGen appoints interim leader Dr. Adam Rogers as permanent CEO to guide the breakthrough.

Peijia Medical submits its innovative GeminiOne heart valve repair system for EU approval, signaling a new challenge to established players in the market.

Median Technologies' eyonis® LCS gains landmark FDA clearance, promising to revolutionize early detection of the deadliest cancer with its AI-powered diagnostics.

Hemex Health's portable Gazelle test gets FDA Breakthrough status, paving an accelerated path for a device already changing lives in over 40 countries.

EMD Serono and the Trump Administration launch a new program offering massive discounts on IVF drugs, bringing hope to millions of aspiring parents.

Delonix Bioworks' next-gen meningitis B vaccine, DX-104, is cleared for human trials in China and Australia, aiming to challenge the market leaders.

Kelun-Biotech's sac-TMT gains its fourth approval in China, doubling survival time for patients with advanced HR+/HER2- breast cancer.

Ascentage Pharma's next-gen BTK degrader, APG-3288, receives dual IND clearance, paving the way for clinical trials to fight resistant blood cancers.

The biotech celebrates its first FDA drug approval, a massive financial boost, and promising new therapies targeting obesity and Alzheimer's disease.

A new drug from Bayer dramatically cuts recurrent stroke risk by 26% without the dangerous bleeding side effects of current therapies, offering hope to millions.

A new study reveals why Sickle Cell Disease patients suffer from frequent crises and rely on pain pills, even with awareness of multi-million dollar cures.

A health-tech firm with a mission for free care and a $1.3B valuation eyes a Nasdaq listing, but its revenue-free history raises critical questions.

A top engineering prize honors John Donoghue for BrainGate, a technology that lets the mind control machines, offering new hope for paralysis and ALS.

New data reveals Orca-T cell therapy boosts survival and cuts complications in blood cancer, as the company prepares for a potential FDA approval this year.