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A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
Treatment of adults with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2]
Breakthrough Therapy Designation was created for drugs that may be significantly better treatments for serious diseases or conditions. [8] On November 13, 2013, the FDA approved obinutuzumab (trade name Gazyva) by Hoffmann-La Roche [9] for chronic lymphocytic leukemia making it the first drug to receive the breakthrough therapy designation.
Tu Youyou (Chinese: 屠呦呦; pinyin: Tú Yōuyōu; born 30 December 1930) is a Nobel Prize-winning Chinese malariologist and pharmaceutical chemist.She discovered artemisinin (also known as qīnghāosù, 青蒿素) and dihydroartemisinin, used to treat malaria, a breakthrough in twentieth-century tropical medicine, saving millions of lives in South China, Southeast Asia, Africa, and South ...
A phase III study indicated that MDMA-assisted therapy represents a potential breakthrough treatment for severe PTSD that merits expedited clinical evaluation. [17] Based on this study, MDMA-assisted psychotherapy was granted breakthrough therapy designation by the FDA, a designation that indicates that there is preliminary evidence that an intervention might offer a substantial improvement ...
It garnered a US FDA Breakthrough Therapy Designation (Dec 2015) for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). [12] It was approved for use in the United States under the brand name YESCARTA in October 2017. [3]
Under the brand name "Sassyfras", MDMA tablets were sold in brown bottles. [250] The Texas Group advertised "Ecstasy parties" at bars and discos, describing MDMA as a "fun drug" and "good to dance to". [251] MDMA was openly distributed in Austin and Dallas–Fort Worth area bars and nightclubs, becoming popular with yuppies, college students ...
Sir Frederick Grant Banting (November 14, 1891 – February 21, 1941) was a Canadian pharmacologist, orthopedist, and field surgeon. [3] For his co-discovery of insulin and its therapeutic potential, Banting was awarded the Nobel Prize in Physiology or Medicine with John Macleod.