USFDA

Clinical research courses

  • Bristol Myers Squibb
    26 February 2025

    USFDA accepts Bristol Myers Squibb’s Supplemental Biologics License Application for Opdivo® Plus Yervoy®

    Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application for Opdivo nivolumab plus Yervoy ipilimumab as a potential first-line treatment option for adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high MSI-H or mismatch repair deficient dMMR colorectal cancer
  • 24 February 2025
    FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease

    the U.S. Food and Drug Administration approved Ctexli for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.

  • 18 February 2025
    MED-EL USA gets FDA approval for cochlear implant
    MED-EL USA announced that the U.S. Food and Drug Administration approved the new SONNET 3 audio processor for MED-EL cochlear implants. SONNET 3 is the companys lightest and smallest behind-the-ear audio processor and features integrated wireless direct streaming capabilities.
  • 30 December 2024
    Halozyme Announces FDA approval of Bristol Myers Squibb's Opdivo Qvantig™ with ENHANZE

    Halozyme Therapeutics, Inc announced that Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme's ENHANZE® drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo® indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

  • 25 December 2024
    FDA approves Zepbound as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity
    Eli Lilly and Company announced the U.S. Food and Drug Administration approved Zepbound tirzepatide as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea OSA and obesity.
  • 19 December 2024
    Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP
    Zydus Life sciences Limited has received final approval from the United States Food and Drug Administration to manufacture Lidocaine and Prilocaine Cream USP.
  • 19 December 2024
    FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
    The U.S. Food and Drug Administration approved Ryoncil remestemcel-L-rknd, an allogeneic donor bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease SR-aGVHD in pediatric patients 2 months of age and older.
  • 19 December 2024
    Granules India Limited announces FDA approval for ADHD Treatment
    Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. , has received approval from the U.S. Food & Drug Administration for its Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Chewable Tablets.
  • 21 November 2024
    Syndax announces FDA approval of Revuforj (revumenib)
    Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Revuforj revumenib as the first and only menin inhibitor for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene KMT2A translocation in adult and pediatric patients one year and older.
  • 29 October 2024
    Iterum Therapeutics receives USFDA approval of ORLYNVAH (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections
    Iterum Therapeutics plc announced that the U.S. Food and Drug Administration has approved Iterums new drug application for ORLYNVAH for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
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