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).
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.
AstraZeneca's immunotherapy Imfinzi (durvalumab) has secured approval from the US Food and Drug Administration (FDA) for unresectable stage III non-small cell lung cancer (NSCLC).
GSK has secured European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older.
Janssen Pharmaceutical’s androgen receptor inhibitor Erleada (apalutamide) has been approved by the US Food and Drug Administration (FDA) for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC).
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