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ACI SANT'ANTONIO: SIFI S.p.A. has issued the following news release: SIFI, a leading international ophthalmic company headquartered in Italy, is pleased to announce that the Committee for Orphan Medicinal Products [...]

Type B meeting feedback confirms SIFI's view that no additional data will be required for potential FDA approval of AKANTIOR AKANTIOR is poised to become the first FDA-approved medication for [...]

This follows the previously granted ODD for polihexanide in Acanthamoeba Keratitis by the FDA and EMA. An estimated 15,660 patients with fungal keratitis are diagnosed annually in the US. CATANIA, [...]

ITALY: RECORDATI has issued the following press release:Recordati today announced that the FDA has granted Orphan Drug Designation to Recordati Rare Disease's investigational product REC 0559 for the treatment of [...]

SILVER : U.S. Food and Drug Administration has issued the following press release: The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of [...]

Silver Spring, MD -- The following information was released by the U.S. Food and Drug Administration: The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for [...]

SILVER SPRING, Md., Aug. 22, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease [...]

MILAN, July 20, 2017 /PRNewswire/ -- Behind the development of cenegermin are decades of Italian research, stemming from the studies of Rita Levi Montalcini, winner of the Nobel Prize in [...]

- miltefosine appears to create miltefosine-induced alterations to the membrane architecture of the amoeba. ORLANDO, Fla., Dec. 19, 2016 /PRNewswire/ -- Profounda, Inc. ('Profounda') announced today that it has received [...]