The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.

Since 2023, the pharmaceutical industry operating in Europe has faced an unprecedented challenge related to drug shortages.

The US Food and Drug Administration (FDA) has approved BridgeBio Pharma ’s Attruby (acoramidis), an oral transthyretin (TTR) ...

TV personality Dr Oz has been nominated by President-elect Donald Trump to lead the Centers for Medicare and Medicaid ...

The UK’s proposed regulations would provide the legal framework for POC manufacturing of cell therapies, including quality assurance.

Johnson & Johnson Innovation Medicine has submitted a request to the FDA to approve Tremfya as a treatment for ulcerative ...

Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

TCR immunotherapy is emerging as a promising, targeted approach for treating solid tumours and other indications.

The biotech uses its AI platform to discover the therapeutic potential of plant-based molecules, advancing ten candidates ...

Amneal Pharmaceuticals has submitted another NDA for its DHE prefilled syringe autoinjector to treat tough-to-treat headaches ...