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FDA approves first biosimilar for the treatment of cancer
Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers…
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U.S. Food and Drug Administration (FDA)
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Nivolumab cuts relapse by one third compared to Ipilimumab
Alternative immunotherapy drug nivolumab is more effective than current standard of care in treating advanced melanoma after surgical removal of disease.
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FDA grants Breakthrough designation to Cemiplimab for CSCC
Cemiplimab receives FDA Breakthrough Therapy Designation for advanced cutaneous squamous cell carcinoma...
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FDA grants orphan drug status to Cellect’s ApoGraft
The FDA has granted orphan drug designation for ApoGraft for the prevention of acute and chronic graft versus host disease...
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FDA approves Mylotarg for treatment of acute myeloid leukemia
The FDA has approved Mylotarg for the treatment of adults with newly diagnosed acute myeloid leukaemia whose tumours express the CD33 antigen...
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FDA approves CAR T cell therapy for children with leukaemia
The FDA has approved CAR T cell therapy for treatment of children with acute lymphoblastic leukemia...
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FDA approves new antibacterial drug
The FDA has approved Vabomere for adults with complicated urinary tract infections...
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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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FDA evaluates prescription opioid medications approved for children
The FDA has heard from professional groups, including the American Academy of Paediatrics about the use of opioid cough suppressants for children...
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FDA grants approval of Besponsa for acute lymphoblastic leukaemia
The FDA has approved Besponsa for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia...
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FDA grants two orphan drug designations for HCC
The FDA has granted two orphan drug designations for T cell therapy products for the treatment of hepatocellular carcinoma...
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Accelerated drugs approval evaluated
Researchers have evaluate the features of pre-approval and post-approval clinical trials of drugs granted Accelerated Approval by the FDA...
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Experimental treatment for Niemann-Pick disease appears safe
An experimental drug has appeared to slow the progression of Niemann-Pick disease type C1...
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Drug approval harmonisation shows savings potential
Researchers have compared the regulatory authorities responsible for approving drugs and medical products to verify their effectiveness and safety...
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FDA drafts guidance on post-approval manufacturing for biologics
The FDA has released a draft guidance in response to an increase in the number of post-approval manufacturing supplements...
