Regulation

Seelos announces FDA acceptance of IND application for SLS-005 for Sanfilippo Syndrome

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company, is pleased to announce the acceptance of the Investigation New Drug (IND) application for SLS-005 (trehalose) by the Food and Drug Administration (FDA).

Mundipharma announces licence extension submission for Invokana and Vokanamet to EMA

As the European distributor of Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin), Mundipharma welcomes the news that the European Medicines Agency (EMA) has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus (T2DM).

GSK submits first regulatory application for daprodustat in Japan

GlaxoSmithKline announced the submission of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anaemia due to chronic kidney disease (CKD).

FDA accepts new drug application for elexacaftor , tezacaftor and ivacaftor combination treatment

Vertex Pharmaceuticals announced the US Food and Drug Administration (FDA) accepted its new drug application (NDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.

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).