Regulatory Approval

With FDA alignment for its pivotal Phase 3 trial, Oncolytics Biotech is poised to bring the first immunotherapy to the challenging pancreatic cancer landscape.

A positive EU opinion for Sobi's Aspaveli could bring the first-ever targeted treatment for two rare kidney diseases, shaking up a market desperate for innovation.

Acadia's new powder form of the only Rett syndrome drug offers families vital choice, easing daily care and showing the power of patient-led innovation.

Genmab's $8 billion acquisition of Merus isn't just a deal; it's a bold strategy to own its destiny and dominate the future of oncology therapeutics.

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.