Regulatory Approval

Tenaya Therapeutics unveils promising interim data for its ARVC gene therapy, TN-401, hinting at a potential cure and igniting investor interest.

Recent CPSC warnings reveal deadly products on the market. As regulators struggle with e-commerce, can AI become the tool we need to stop them?

Recent product recalls reveal deep flaws in our safety systems. What can this teach us about regulating the complex world of medical AI before it's too late?

Early results for INT230-6 show 50% fewer severe side effects, raising hopes for a treatment that could eliminate the toxic 'red devil' chemo.

Praxis Precision Medicines secures a clear path to market for its rare epilepsy drug, blending genetic science with a savvy regulatory strategy.

Abeona Therapeutics' new treatment center for ZEVASKYN marks a strategic leap in gene therapy access, but what does it mean for patients and the market?

A breakthrough genetic therapy for ALS offers hope, but a split verdict from Canadian health agencies reveals the tough calculus of innovation versus cost.

Promising interim data for a Parkinson's vaccine sends AC Immune's stock soaring, signaling a potential paradigm shift from symptom management to disease modification.

With its pivotal trial fully enrolled, IDEAYA Biosciences is on track for a 2026 FDA filing for a new treatment in a rare, deadly eye cancer.

A Belgian med-tech firm is replacing a centuries-old procedure with an implantable pump, targeting a growing multi-billion dollar liver disease market.

An energy services giant just sold its nuclear arm to a startup in a stock deal. It's a strategic pivot to mass-produce reactors for the AI power crunch.

Serina Therapeutics has answered the FDA's challenge. A 30-day clock now ticks on its novel Parkinson's therapy and its disruptive drug delivery platform.

Early trial data suggests GRI-0621 could be a game-changer for Idiopathic Pulmonary Fibrosis, showing lung repair and a much better safety profile.

Aardvark Therapeutics' pivotal trial for Prader-Willi syndrome goes global, a key step toward commercializing its novel hunger-suppressing drug.

Beyond a simple FDA approval, Amneal's entry into the epinephrine vial market is a calculated move to fix a broken supply chain and drive growth.

PathAI's AIM-MASH tool just got dual FDA/EMA approval, a first for AI pathology. This could slash MASH drug development time and reshape clinical trials.

Clene Inc. heads to an investor conference with powerful new ALS data. But with a limited cash runway, the real test is securing market confidence.

AskBio's gene therapies for Parkinson's and heart failure have received Japan's SAKIGAKE designation, promising a faster path to patients.

A new lab system combines speed, multiplexing, and regulatory trust, promising to accelerate drug development and deepen our biological understanding.

For those with severe PTSD and depression, hope is scarce. Biotech firm Compass Pathways is pioneering a psilocybin treatment that could change everything.