Regulation

FDA grants fast track status to Moderna’s Zika vaccine

Moderna, a biotechnology company, has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational Zika vaccine, mRNA-1893.

AbbVie receives FDA approval of RINVOQ for moderate to severe rheumatoid arthritis

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’s Inrebic gets FDA approval for myelofibrosis

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.

European Medicines Agency validates marketing application for Filgotinib for the treatment of rheumatoid arthritis

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 gets FDA nod for Rozlytrek to treat ROS1-positive NSCLC

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).

Janssen gets EC approval for two new indications of Imbruvica

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the European Commission (EC) for two new indications of Imbruvica (ibrutinib).

Novartis’ Sandoz to appeal US district court ruling on biosimilar Erelzi

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 receives FDA complete response letter for KPI-121 0.25% NDA

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 granted FDA orphan drug designation for STK-001 for Dravet Syndrome

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.