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Biktarvy approved for the treatment of HIV-1 infection
The FDA has approved Biktarvy a once-daily single-tablet regimen for the treatment of HIV-1 infection...
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U.S. Food and Drug Administration (FDA)
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EC grants orphan drug designation for Gilteritinib for the treatment of AML
The European Commission has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia...
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FDA accepts IND for the treatment of mucopolysaccharidosis type IIIA
The FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug application for the drug candidate SOBI003...
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Report calls into question effectiveness of pyridoxine-doxylamine
Previously unpublished information from the clinical trial that the FDA relied on to approve the most commonly prescribed medicine for nausea in pregnancy indicates the drug is not effective...
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FDA approves new indication for Gilotrif in EGFR mutation-positive NSCLC
The FDA has approved a supplemental New Drug Application for Gilotrif for the first-line treatment of patients with metastatic non-small cell lung cancer...
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FDA approves lynparza for breast cancer with BRCA gene mutation
The FDA has expanded the approved use of Lynparza to include the treatment of patients with metastatic breast cancer who have a BRCA gene mutation...
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FDA revises labelling in prescription cough and cold products to protect children from opioids
FDA acts to protect children from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labelling to limit paediatrics use...
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Upadacitinib receives breakthrough therapy designation for atopic dermatitis
Phase 3 clinical program for upadacitinib in atopic dermatitis, the most common type of eczema, is planned to begin in the first half of 2018...
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Obstacles to success for biosimilars in the US market
Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five. The FDA, however, since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2009,2 has licensed six products under PHS 351(k) of the Public Health Service (PHS) Act; approved one product under…
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FDA approves Nucala for Eosinophilic Granulomatosis with Polyangiitis
The FDA has expanded the approved use of Nucala to treat a rare autoimmune disease that causes vasculitis, an inflammation of the wall of blood vessels of the body...
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FDA approves Admelog, the first follow-on insulin product to treat diabetes
The FDA has approved Admelog, a short-acting insulin indicated to improve control in blood sugar levels in diabetes...
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FDA approves first once-monthly buprenorphine injection for OUD
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for moderate-to-severe opioid use disorder...
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Tudorza reduces exacerbations in COPD patients
AstraZeneca has announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair in patients with moderate to very severe COPD...
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Ogivri approved as the first biosimilar against certain breast and stomach cancers
The FDA has approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumours overexpress the HER2 gene...
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FDA approves Hemlibra to prevent bleeding in patients with haemophilia A
Hemlibra has been approved to prevent the frequency of bleeding episodes in patients who have developed FVIII inhibitors...
