FDA加速审批Lipocine的肌肉萎缩症治疗药物
快速通道计划旨在加速开发和审查治疗严重疾病且存在未满足医疗需求的药物。LPCN 1148获得这一资格后,可以更频繁地与FDA互动,有资格获得加速批准和优先审查,并可能进行新药申请的滚动审查。
The Herald Journal10 天
FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia ...
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment ...
Lipocine's LPCN 1148 Gets Fast Track Status To Treat Sarcopenia In Decompensated Cirrhosis ...
Lipocine Inc. (LPCN), a biopharmaceutical company, Tuesday said that the U.S. Food and Drug Administration or FDA has granted Fast ...
Morningstar11 天
FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia ...
LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in the ...
Lipocine granted FDA Fast Track Designation for LPCN 1148
Lipocine (LPCN) announced that the U.S. FDA has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with ...
Nasdaq10 天
Lipocine's LPCN 1148 Gets Fast Track Status To Treat Sarcopenia In Decompensated Cirrhosis ...
(RTTNews) - Lipocine Inc. (LPCN), a biopharmaceutical company, Tuesday said that the U.S. Food and Drug Administration or FDA has granted Fast Track Designation to LPCN 1148, the company's drug ...
Nasdaq10 天
Lipocine granted FDA Fast Track Designation for LPCN 1148
Lipocine (LPCN) announced that the U.S. FDA has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of ...
Lipocine Inc.: FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment ...
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment ...