Approvals

Roche gets FDA breakthrough therapy designation for Gazyva to treat lupus nephritis

Roche has secured a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its Gazyva (obinutuzumab) to treat adults with lupus nephritis.

FDA approves Keytruda plus Lenvima to treat advanced endometrial carcinoma

Merck and Eisai have announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) plus Lenvima (lenvatinib) to treat patients with certain types of endometrial carcinoma.

CTD Holdings announces FDA approval of US expanded access treatment program in Niemann-Pick Disease Type C

CTD Holdings, a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced that the company will provide Trappsol Cyclo, its proprietary hydroxypropyl beta cyclodextrin drug, to a pediatric patient diagnosed with Niemann-Pick Disease Type C.

FDA approves GSK’s Nucala for young children with severe eosinophilic asthma

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Nucala (mepolizumab) to treat children as young as six years old living with severe eosinophilic asthma.

FDA approves Xeris’ GVOKE injection for treatment of severe hypoglycaemia

The US Food and Drug Administration (FDA) has approved Xeris Pharmaceuticals’ GVOKE (glucagon) injection for the treatment of severe hypoglycaemia in paediatric and adult patients having diabetes, aged two years and above.

Acceleron gets FDA orphan drug designation for sotatercept in pulmonary arterial hypertension

Acceleron Pharma, a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).

Boehringer Ingelheim’s Ofev secures FDA approval for SSc-ILD

Boehringer Ingelheim Pharmaceuticals has secured approval for Ofev (nintedanib) capsules from the US Food and Drug Administration (FDA) for the treatment of interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD).

SunGen Pharma receives seventh ANDA approval from US FDA

SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its seventh ANDA approval from the US Food and Drug Administration (FDA).

Endo announces approval of first generic Orfadin in US

Endo International announced that Novitium Pharma, a partner of its subsidiary Endo Ventures, received approval from the US Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).