iPhone | iPad
Android
Huawei
Tens of thousands lined the streets of capital Dili, waving Vatican-coloured flags and umbrellas while screaming as the 87-year-old was driven through the streets flanked by security
KT APPDOWNLOAD
US FDA approves Citius' blood cancer therapy
Lymphir is expected to launch within the next five months and is approved for certain adult patients with relapsed cutaneous T-cell lymphoma, a group of rare blood cancers that affects the skin
The corporate logo of the US Food and Drug Administration is shown in Silver Spring, Maryland, on November 4, 2009. — Reuters file
The US Food and Drug Administration has approved Citius Pharmaceuticals' blood cancer therapy, Lymphir, for relapsed patients who have received at least one prior treatment, the company said on Thursday.
The approval comes after the health regulator initially declined to approve the therapy last year, seeking additional product testing data.
Lymphir, Citius' first approved treatment, is expected to launch within the next five months and is approved for certain adult patients with relapsed cutaneous T-cell lymphoma, a group of rare blood cancers that affects the skin.
The cancer has an incidence rate of 8.55 in one million people in the United States, according to government data.
The FDA's approval is based on data from a late-stage trial, which showed that 36.2 per cent of patients treated with Lymphir showed partial or complete response to the treatment while reducing skin disease in 84 per cent of patients in the study.
Citius acquired the licensing rights to Lymphir from India's Dr Reddy's Laboratories for an upfront payment of $40 million. Dr Reddy's is also entitled to an additional $40 million in milestone payments related to US approval of the therapy.
More news from World
More than 600 people were killed in the weeks leading up to Hasina's ouster, according to a preliminary United Nations report
Some 1.5 million people were still without electricity on Monday and a major bridge across the swollen and fast-moving Red River collapsed in northern Phu Tho province
The attack also wounded at least 15 others
The protests started across Japan, Australia, Taiwan and Singapore, before spreading to cities in several European countries and to the US
The patient has been isolated in a hospital and is in a stable condition, according to the health ministry
The 87-year-old pope is visiting Papua New Guinea as part of his ambitious 12-day, four-country tour of Southeast Asia and Oceania, the longest of his 11-year-old papacy
Authorities were searching for Joseph Couch, considered a person of interest in the shooting that temporarily closed I-75 in both directions