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Latest Pharma-News

Bristol-Myers Squibb Company announced U.S. FDA accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line...

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Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for the Treatment of Essential Thrombocythemia

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MorphoSys and Incyte Sign Global Collaboration and License Agreement for Tafasitamab development for the treatment of the B cell malignancies

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CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab as an adjuvant therapy for the Treatment of Metastatic Triple-Negative...

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Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for the treatment of Tumor-Induced Osteomalacia (TIO)

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BioCryst to Provide Berotralstat and BCX9930 Program Updates at 38th Annual J.P. Morgan Healthcare Conference

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FDA grants breakthrough device designation to Reflow Medical’s temporary spur stent system for the treatment of below-the-knee (BTK) peripheral artery disease

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Novartis ligelizumab (QGE031) more effective than Xolair®(omalizumab) at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria

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Bayer and Evotec form a new strategic alliance focusing on the treatment of polycystic ovary syndrome

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Regulatory Affairs

Approval pathways of Fixed dose combination (FDC) in India

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Clinical Data Management

When to Start and Stop collecting Adverse Events

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