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.
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 has secured approval for Mayzent (siponimod) in the European Union (EU) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.
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 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).
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).
Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
Specialist HIV company ViiV Healthcare has secured Japanese approval for Dovato (dolutegravir 50mg/lamivudine 300mg) two-drug regimen to treat of HIV-1 infection.
ViiV Healthcare has completed a regulatory filing in Europe seeking the approval for fostemsavir for the treatment of HIV-1 infection in adult patients having limited treatment options.
Alnylam Pharmaceuticals has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1 (PH1).
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.