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).
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).
Specialist HIV company ViiV Healthcare has secured Japanese approval for Dovato (dolutegravir 50mg/lamivudine 300mg) two-drug regimen to treat of HIV-1 infection.
Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).
Biopharmaceutical company Ipsen has secured approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its Dysport as a symptomatic treatment for upper limb spasticity in children with cerebral palsy.
AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib) as a first-line maintenance treatment for germline BRCA-mutated metastatic pancreatic cancer.
Roche has secured approval from the European Commission (EC) for its Kadcyla (trastuzumab emtansine) as an adjuvant (after surgery) treatment for people with HER2-positive early breast cancer (eBC).
Astellas Pharma and Seattle Genetics have secured accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) to treat people with locally advanced or metastatic urothelial cancer.
Dicerna Pharmaceuticals has secured orphan drug designation from the European Commission (EC) for its DCR-A1AT to treat congenital alpha-1 antitrypsin (A1AT) deficiency.
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