MedPage Today10h
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 ...
Targeted Oncology11h
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 ...
Malaria developing resistance to drug used to treat children
The malaria parasite may be gaining resistance against artemisinin, the drug most often used to try and save children with ...
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 ...
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 ...
FiercePharma2d
Marinus cuts 45% of staff after key medicine stumbled in pair of phase 3 trials
Last month, a second phase 3 blow for Marinus Pharmaceuticals prompted the Pennsylvania-based drugmaker to turn an eye toward ...
FiercePharma2d
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 ...