fda the type c meeting 美国食品和药物管理局C型会议 fda the type c meeting 美国食品和药物管理局C型会议
”“our,”“us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Type C meeting request to discuss the company’s p...
Longeveron Inc. recently announced the positive Type C meeting with the US FDA supporting the advancement of Lomecel-B, a proprietary, scalable, allogeneic, investigational cellular therapy currently being evaluated in a Phase 2b clinical trial (ELPIS II) for hypoplastic left heart syndrome (HLHS)....
a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, will host a conference call to discuss feedback received from its ...
The FDA and Eagle Pharmaceuticals have agreed on the next steps for the development of EA-114, an estrogen receptor antagonist and novel formulation of fulvestrant (Faslodex) used in the treatment of postmenopausal women with breast cancer. The consensus was reached in a Type...
The Niemann-Pick Type C (NPC) externally led Patient-Focused Drug Development (PFDD) meeting is a groundbreaking initiative that will give persons with NPC disease and their advocates the opportunity to provide the Food and Drug Administration (FDA), drug developers, and NPC stakeholders with pers...
After a Type A meeting with the FDA regarding oral paclitaxel/encequidar in metastatic breast cancer, Athenex, Inc. has announced that they will be deploying their resources to other avenues of research. The biopharmaceutical company Athenex Inc. has shared that they will be shifting...
"We're pleased to report we recently met with the FDA to align on the content of our IND resubmission for CMND-100," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. "The meeting was informative and productive, and we're eager to advance the U.S. regulatory process and po...
Clearmind Medicine Inc. today announced it has completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company’s clinical trial of its proprietary MEAI-based, CMND-100 compound. Tel Aviv, Israel / Vancouver, Canada, Jan. 10, 2024 (GLOBE NEWSWIRE) -...
"We're pleased to report we recently met with the FDA to align on the content of our IND resubmission for CMND-100," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “The meeting was informative and productive, and we’re eager to advance the U.S. regulatory pro...