The US Food and Drug Administration (FDA) has approved Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission in adults and children.
Fennec Pharmaceuticals has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Pedmark to prevent cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).
The European Commission has granted orphan drug designation to the Soligenix recombinant modified ricin toxin A-chain subunit (the active pharmaceutical ingredient in RiVax) for the prevention of ricin poisoning.
The US Food and Drug Administration (FDA) has expanded the indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Seattle Genetics’ Adcetris (Brentuximab Vedotin) in combination with chemotherapy has been approved by the US Food and Drug Administration (FDA) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).
The US Food and Drug Administration (FDA) has accepted Pfizer and Astellas Pharma's supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for a new indication and granted priority review designation.
The US Food and Drug Administration (FDA) has approved CSL Behring’s Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
Destiny Pharma’s has secured fast track designation from the US Food and Drug Administration (FDA) for its lead clinical candidate exeporfinium chloride (XF-73) for the prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA).
Proteostasis Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its PTI-428, which is a cystic fibrosis transmembrane conductance regulator (CFTR) amplifier drug candidate.
Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of advanced cervical cancer.
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