MedPage Today5h
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 ...
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 ...
Hosted on MSN2d
Intercept loses Ocaliva FDA full approval bid in rare liver disease
On the heels of an unfavourable advisory committee (AdCom) meeting, the US Food and Drug Administration (FDA) has decided not ...
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 ...
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 ...
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 ...
Business Insider2d
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 ...
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 ...
CNET4d
Which Decongestants Are Effective? Why the FDA Wants to Pull a Popular Medicine Ingredient
And according to survey information compiled for the FDA meeting by the Consumer Healthcare Products Association, many people are happy with products containing phenylephrine and say they've found ...
Yahoo Finance4d
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 ...
Targeted Oncology6h
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 ...