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.
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).
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).
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
NeuroVive Pharmaceutical AB announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.
Epizyme announced that the US Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent.
Merck and Eisai have been granted breakthrough therapy designation from the US Food and Drug Administration (FDA) for their Keytruda and Lenvima combination for unresectable hepatocellular carcinoma (HCC).
Johnson & Johnson’s Janssen Pharmaceutical is seeking extension of approval in the European Union for Darzalex (daratumumab) in a subcutaneous formulation for the treatment of multiple myeloma.
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