Regulation

European Medicines Agency validates Kite’s marketing application for second CAR T cell therapy

Kite, a Gilead Company announced that the company’s Marketing Authorization Application (MAA) for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), has been fully validated and is now under evaluation by the European Medicines Agency (EMA).

FDA approves Merck’s DIFICID to treat Clostridioides difficile in children aged six months and older

Merck, known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.

Epizyme gets FDA approval for Tazverik to treat epithelioid sarcoma

Epizyme has secured accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat pateints epithelioid sarcoma.

Jazz Pharmaceuticals submits NDA for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy

Jazz Pharmaceuticals announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration on January 21, 2020 seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

FDA approves TEPEZZA for the treatment of thyroid eye disease

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved TEPEZZA (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED).

Novartis’ Mayzent gets EC nod for secondary progressive multiple sclerosis

Novartis has secured approval for Mayzent (siponimod) in the European Union (EU) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.

Jazz Pharmaceuticals receives EU marketing authorisation for Sunosi for excessive daytime sleepiness in adults with narcolepsy or OSA

Jazz Pharmaceuticals announced that the European Commission approved Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

AstraZeneca gets FDA orphan drug status for Imfinz plus tremelimumab to treat hepatocellular carcinoma

AstraZeneca has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) and tremelimumab to treat liver cancer called hepatocellular carcinoma (HCC).

Janssen seeks EMA nod for Imbruvica, rituximab combo in previously untreated CLL

The Janssen Pharmaceutical Companies of Johnson & Johnson has applied to the European Medicines Agency (EMA) seeking the approval of Imbruvica (ibrutinib) in combination with rituximab as first-line treatment in previously untreated chronic lymphocytic leukaemia (CLL).