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Drug Development

      Chinas National Medical Products Administration Approves Harvoni for Treatment of Chronic Hepatitis C Virus Genotype

      FDA Approvals
      Gilead Sciences announced that the National Medical Products Administration (NMPA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) in China for the treatment of...

      Stem Cell Medicine Licenses Exosome Technology for Treating Autism from Ramot at Tel Aviv University

      Drug Development
      Stem Cell Medicine Ltd. (SCM), a biotechnology company developing new therapies for neurological indications, including mesenchymal stem cells and anti-BMP molecules for the treatment...

      FDA approves Roches Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer

      FDA Approvals
      Roche announced that the US FDA approved Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with...

      Bluebird bio and Celgene Corporation Present Initial Data from Phase 1 Clinical Study of Next-Generation Anti-BCMA CAR T Cell Therapy

      Clinical Trials
      Bluebird bio, Inc. and Celgene Corporation announced initial data from the ongoing Phase 1 clinical study of bb21217 (CRB-402), an investigational next-generation anti-BCMA CAR...

      EMA Accepts Extension Marketing Authorisation Application for Review of Celltrions Remsima SC the subcutaneous version of Remsima

      Drug Development
      Celltrion, Inc. announced that the EMA has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of...

      QPS Expands U.S.-Based Phase I Clinical Trial Capabilities to Support the Growing Needs of Its Pharmaceutical, Biotechnology and CRO Partners

      Clinical Trials
      QPS, a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development, announced the expansion of its U.S.-based Phase I clinical trial...

      Shire Receives European Approval for TAKHZYRO (lanadelumab) subcutaneous injection for the Preventive Treatment of Hereditary Angioedema

      FDA Approvals
      Shire plc the leading global biotechnology company focused on rare diseases, announced that the European Commission (EC) has granted Marketing Authorisation for TAKHZYRO™ (lanadelumab)...

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      The Future of Digital Health

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      The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....

      Five Best Practices to Deliver Exceptional Multichannel Experiences

      Whitepapers 0
      A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...

      The Impact and Use of Social Media in Pharmacovigilance

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      Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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