MedPage Today13h
Clozapine's REMS Program on the Chopping Block at Upcoming FDA Meeting
"Severe neutropenia occurs in a small percentage of patients taking clozapine; however, neutropenia is associated with an ...
FiercePharma3d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
PharmaTher Secures FDA Meeting for Ketamine Drug
PharmaTher Holdings Ltd (TSE:PHRM) has released an update. PharmaTher Holdings Ltd. has secured a meeting with the FDA to address a complete ...
Targeted Oncology14h
FDA Approves Revumenib in KMT2A-Rearranged Acute Leukemia
Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute ...
JD Supra1d
FDA Advisory Committee outlines informed consent best practices
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
MedPage Today4d
FDA Rejects Full Approval of Liver Disease Drug
Opens in a new tab or window The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary ...
FiercePharma3d
After election, FDA's Califf lays out hopes for his Trump-appointed successor
“I think ability to function as an executive is going to be a very important one,” Califf said Tuesday at the Friends of ...
JD Supra2d
Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
Liam Payne's Alleged Drug Dealer Confirms Meeting At Hotel; Took Pics Together
Braian Paiz, the alleged drug dealer of former One Direction member Liam Payne, has spoken up about their encounters. In an ...
Yahoo Finance5d
IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial
As part of the process, the company will be conducting an ‘End-of-Phase 2’ meeting with the FDA later this month to get input from the agency on their proposed trial design. The study is ...
manilatimes3d
PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application
On November 12, 2024, the FDA granted the Meeting scheduled for November 29, 2024. Due to the U.S. Thanksgiving Holiday and scheduling conflicts of attendees from its CDMO partner, the Company has ...