Press Releases

Astrazeneca’s Imfinzi for unresectable Stage III non-small cell lung cancer gets FDA approval

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US FDA has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following...

Allergan Presents Data at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego

The meeting will be held at the San Diego Convention Center and the scheduled times (noted in local Pacific Time) for the Allergan presentations, titles and authors are as follows: Podium PresentationsOnce-Daily Oral Sarecycline 1.5 mg/kg/day...

Amgen sets up a FDA Advisory Committee Meeting To Review Potential New Use Of BLINCYTO

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 presents New, Late Breaking Investigational Data at 2018 at AAD Annual meeting

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’S Fluarix Tetra (Influenza Vaccine) for ages six months and older RECEIVES European Approval

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...

GSK submits landmark IMPACT data to European Medicines Agencies for supporting Trelegy Ellipta

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...

FDA Approves Symdeko

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...

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