"Severe neutropenia occurs in a small percentage of patients taking clozapine; however, neutropenia is associated with an ...
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
On the heels of an unfavourable advisory committee (AdCom) meeting, the US Food and Drug Administration (FDA) has decided not ...
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
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 ...
PharmaTher Holdings Ltd (TSE:PHRM) has released an update. PharmaTher Holdings Ltd. has secured a meeting with the FDA to address a complete ...
Opens in a new tab or window The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary ...
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 ...
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 ...
Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute ...
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