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

    • Fanaptum

    - PMLiVE

    EMA reaffirms guidance on paracetamol use during pregnancy

    The guidance follows recent US comments about a possible link to autism

    - PMLiVE

    Johnson & Johnson seeks first EMA approval for icotrokinra for plaque psoriasis

    Icotrokinra is a first-in-class, once-daily tablet for moderate-to-severe plaque psoriasis

    - PMLiVE

    EMA orphan drug designation given to ReAlta for graft-versus-host disease therapy

    This follows preliminary results from the company's ongoing phase 2 trial

    - PMLiVE

    Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

    The reference medicine holds approvals for multiple HER2-positive breast cancer indications

    Biogen Idec building

    Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA

    The neuromuscular disease affects approximately one in every 10,000 babies worldwide

    - PMLiVE

    Pfizer/BioNTech’s KP.2-adapted COVID-19 vaccine receives CHMP recommendation

    The updated vaccine was shown to generate an improved response against currently circulating variants

    tijana being interviewed

    Envision Analogue – An Introduction

    Powered by primary payer market research, Envision is an online platform that provides forward-looking evaluations and comprehensive strategic direction for market access viability after an oncology product has received positive...

    Genesis Research Group

    - PMLiVE

    AstraZeneca’s Tagrisso combination receives CHMP recommendation for advanced lung cancer

    More than 450,000 people are diagnosed with lung cancer every year in Europe

    - PMLiVE

    Pfizer’s one-time haemophilia B therapy Durveqtix receives CHMP recommendation

    More than 38,000 people worldwide are currently affected by the inherited bleeding disorder

    - PMLiVE

    CHMP recommends use of Moderna’s Omicron BA.1 booster in children in the EU

    The company is also evaluating the use of the vaccine in children aged from six months

    - PMLiVE

    Sanofi/ Regeneron’s Dupixent recommended by CHMP to treat eosinophilic oesophagitis

    Patients in a phase 3 trial experienced improvements in their ability to swallow after four weeks

    - PMLiVE

    AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

    The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

    Subscribe to our email news alerts

    Latest content

    Latest intelligence

    Quick links