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.
Sarepta Therapeutics has is planning to submit a new drug application (NDA) for accelerated approval of its duchenne muscular dystrophy (DMD) drug Golodirsen (SRP-4053).
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.
Endo International has won a preliminary injunction in the US, barring QuVa Pharm from introducing a compounding drug that could compete with its Vasostrict, the vasopressin injection indicated to increase blood pressure in adults with vasodilatory shock.
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).
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