Pharmafile Logo
  • - PMLiVE
  • - PMLiVE
  • Diversity, Equity and Inclusion
  • Communiqué 53 Cover Image

    • FDA

    - PMLiVE

    Havas Life London unveils AI awareness campaign

    The campaign highlights the dangers of AI misinformation in rare disease

    - PMLiVE

    FDA approves first gene therapy for Wiskott-Aldrich syndrome

    Symptoms of the rare disease include bleeding, eczema and frequent infections

    - PMLiVE

    FDA launches TEMPO digital health pilot

    Digital technologies can improve remote patient care for those with chronic diseases

    - PMLiVE

    Richard Pazdur, FDA’s drug evaluation chief, to leave FDA just weeks into new role

    Pazdur was previously head of the FDA’s Oncology Center of Excellence

    - PMLiVE

    Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

    Cladribine capsules could become the first ever oral treatment for gMG

    - PMLiVE

    AstraZeneca announces $2bn investment in US manufacturing

    The new and expanded facilities will support production of rare disease drug treatments

    - PMLiVE

    AstraZeneca reports positive results from rare disease trial

    HES is a group of rare disorders characterised by persistently elevated levels of white blood cells

    - PMLiVE

    Johnson & Jonson secures FDA approval for multiple myeloma treatment

    Support for first and only high-risk smouldering multiple myeloma treatment came from positive phase 3 trial results

    - PMLiVE

    GSK’s Blenrep approved by FDA for multiple myeloma

    Approval supported by positive results from phase 3 trial

    - PMLiVE

    MHRA and FDA expand collaboration on AI and medtech regulation

    National Commission on the Regulation of AI in Healthcare brings together UK and US experts

    - PMLiVE

    Roche’s small cell lung cancer therapy approved by FDA

    This is the first and only approved combination therapy for extensive-stage small cell lung cancer

    - PMLiVE

    Eli Lilly’s Inluriyo approved by FDA for breast cancer

    The oral drug can be used to treat advanced or metastatic breast cancer

    Subscribe to our email news alerts

    Latest content

    Latest intelligence

    Quick links