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.
GlaxoSmithKline has received approval from the European Commission for a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting β2-agonist.
Roche’s Hemlibra (emicizumab) has been approved by the European Commission (EC) as a prophylactic treatment for bleeding episodes in patients with hemophilia A with factor VIII inhibitors.
Shionogi's new drug application (NDA) for lusutrombopag (S-888711) has been accepted for filing and granted priority review by the US Food & Drug Administration (FDA).
Eli Lilly and Company has secured additional approval from the US Food and Drug Administration (FDA) for Verzenio (abemaciclib) as initial treatment for advanced breast cancer.
KemPharm has secured approval from the US Food and Drug Administration (FDA) for its opioid painkiller, Apadaz, for the short-term management of acute pain.
Mylan has secured tentative approval from the US Food and Drug Administration (FDA) for its fixed-dose HIV combination therapy Dolutegravir/Emtricitabine/Tenofovir Alafenamide (DTG/FTC/TAF 50 mg/200mg/25mg) tablets.
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