Epizyme has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.
German neurotoxin firm Merz has secured European approval for its Xeomin (incobotulinumtoxinA) for the symptomatic treatment of chronic sialorrhea (drooling) due to neurological disorders in adult patients.
Santhera Pharmaceuticals has filed a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD).
Celgene has secured approval from the US Food and Drug Administration (FDA) for its Revlimid (lenalidomide) in combination with a rituximab product (R²) to treat adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL).
Teva Pharmaceuticals USA and related affiliates of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and the state of Oklahoma, have entered into an agreement for a one-time payment of $85 million to the state.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its breast cancer drug combo Piqray (alpelisib, formerly BYL719) plus fulvestrant.
The US Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.
GlaxoSmithKline (GSK) has secured approval from China’s National Medical Products Administration (NMPA) for Shingrix vaccine to prevent shingles (herpes zoster) in adults aged 50 years or older.
Mayne Pharma Group has announced that the US Food and Drug Administration (FDA) has approved SORILUX (calcipotriene) Foam, 0.005% in adolescents.
Takeda Pharmaceuticals, announced today that the US Food and Drug Administration (FDA) approved extending the indication of GATTEX (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding.
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