Regulation

GSK gets EU approval for labelling update to Relvar Ellipta in patients with asthma

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 wins preliminary injunction against QuVa in vasopressin case

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 hemophilia drug Hemlibra secures approval in Europe

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.

FDA grants priority review to Shionogi’s lusutrombopag

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).

Lilly’s breast cancer drug Verzenio secures another approval in US

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.

FDA approves KemPharm’s Apadaz for short-term pain management

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 bags FDA’s tentative approval for fixed-dose HIV combo therapy

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 Imfinzi wins FDA approval for lung cancer treatment

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’s Fluarix Tetra wins European approval for expanded indication

GSK has secured European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older.