Approvals

US and European regulators accept AstraZeneca’s applications for cancer treatments

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).

FDA approves new indication for Amgen’s leukemia drug Blincyto

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’ Pedmark gets FDA breakthrough status

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).

Soligenix gets orphan drug designation from European Commission for RiVax to prevent Ricin poisoning

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.

FDA expands approval for Novartis’ Tasigna to treat children with rare form of leukemia

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).

FDA expands approval of Seattle Genetics’ Adcetris for advanced classical Hodgkin Lymphoma

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).

FDA grants Xtandi priority review for Nonmetastatic CRPC

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.

FDA approves Hizentra to treat chronic inflammatory demyelinating polyneuropathy

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 XF-73 MRSA drug gets FDA fast track designation

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).