AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).
Celgene has secured approval from the US Food and Drug Administration (FDA) for its Inrebic (fedratinib) to treat adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.
Gilead Sciences and Galapagos announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and is now under evaluation by the European Medicines Agency (EMA).
Roche has secured approval from the US Food and Drug Administration (FDA) for its Rozlytrek (entrectinib) to treat adults with ROS1-positive and metastatic non-small cell lung cancer (NSCLC).
The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the European Commission (EC) for two new indications of Imbruvica (ibrutinib).
Novartis’ Sandoz said that it will appeal the ruling of a US district court pertaining to the patent infringement case on Erelzi (etanercept-szzs), the company’s biosimilar to Amgen’s Enbrel (etanercept).
Kala Pharmaceuticals announced that it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the company’s new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
Stoke Therapeutics, a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product candidate, STK-001, an investigational new treatment for Dravet syndrome.
Alnylam Pharmaceuticals’ investigational RNAi therapeutic givosiran has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of acute hepatic porphyria (AHP).
Daiichi Sankyo has secured approval from the US Food and Drug Administration (FDA) for the use of Turalio (pexidartinib) for the treatment of symptomatic tenosynovial giant cell tumor (TGCT).
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