Press Releases

Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. FDA will review data supporting the BLINCYTO® (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia...

AbbVie  a global research and development-based biopharmaceutical company, today announced it will present new, late-breaking data across investigational medicines and HUMIRA® (adalimumab) at the 2018 American Academy of Dermatology (AAD) Annual Meeting (February 16-20, San Diego). ...

GSK announced the expanded indication for Fluarix Tetra (Quadrivalent Influenza Vaccine) has been approved in Europe to include adults and now children from six months of age for the prevention of influenza disease caused by the two influenza A...

GlaxoSmithKline plc and Innoviva, Inc. announced the submission of the landmark IMPACT data to the European Medicines Agency as part of a type II variation to support an expanded label for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) in Europe for...

Vertex Pharmaceuticals Incorporated announced that the U.S. FDA approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic...

The U.S. FDA approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment...

CRF Health, a leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, announced that its electronic informed consent solution, TrialConsent®, has won the 2018 Best Practices Award at this year’s Clinical Informatics News...