AstraZeneca’s Fasenra (benralizumab) has been granted orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of eosinophilic oesophagitis (EoE).
The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes.
Johnson & Johnson (NYSE: JNJ) and its Janssen Pharmaceutical Companies today announced they will appeal the $572 million civil judgment entered in Cleveland County District Court in the State of Oklahoma’s lawsuit against opioid manufacturers.
Eli Lilly and Company (Lilly) has secured approval for its monoclonal antibody Taltz (ixekizumab) from the US Food and Drug Administration (FDA) for the treatment of active ankylosing spondylitis (AS) in adults.
GlaxoSmithKline’s (GSK) immuno-conjugate belantamab mafodotin (GSK2857916) has achieved its primary objective in the multiple myeloma trial.
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).
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).
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).
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.
Moderna, a biotechnology company, has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational Zika vaccine, mRNA-1893.
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