Food and Drug Administration (FDA)
NEWS
For fiscal year 2019, the agency reported 1,171 generic drug approvals, 935 of them full approvals and 236 tentative approvals. This is up from last year’s all-time record of 971 generic drug approvals.
The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has granted Fast Track designation to T-Guard, Xenikos’ flagship product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
The patch is a once-per-day treatment that provides sustained concentrations of Secuado (asenapine), an atypical antipsychotic drug used to treat schizophrenia.
Motif Bio plc announced that the Company has received the official minutes of the Type B meeting with the U.S. Food & Drug Administration which took place on September 19, 2019..
The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Xarelto for the prevention of venous thromboembolism, or blood clots, in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
The U.S. Food and Drug Administration approved Eli Lilly’s Reyvow (lasmiditan) for the acute treatment of migraines.
As Gilead Sciences and its development partner Galapagos NV eye filing a New Drug Application with the U.S. Food and Drug Administration for its JAK inhibitor filgotinib, the companies’ hopes have been boosted by new 52-week safety data.
The grants were awarded through the FDA’s Orphan Products Clinical Trials Grants Program that was provided by Congress to specifically encourage the development of treatments for rare diseases.
Scenesse is an under-the-skin implant. The drug is the company’s only approved product.
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