Outrage Of The Month: FDA Approval of Brexpiprazole for Agitation Symptoms Associated With Dementia Due to Alzheimer’s Disease — False Hopes for Patients and Families? June 1, 2023
Testimony before the FDA’s Gastrointestinal Drugs Advisory Committee regarding the possible accelerated approval of obeticholic acid (NDA# 212833) to treat nonalcoholic steatohepatitis with fibrosis May 19, 2023
Testimony before the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Regarding SRP-9001 (delandistrogene moxeparvovec) for the Treatment of Duchenne Muscular Dystrophy May 12, 2023
Press Releases FDA Should Reject Approval of Dangerous Antipsychotic to Prevent Harm to Agitated Patients with Alzheimer’s Dementia May 3, 2023
Letter to the FDA Opposing Approval of Brexpiprazole for the Treatment of Agitation Associated with Alzheimer’s Dementia May 3, 2023
Press Releases Petition: FDA Should Promptly Add Banned Medication to List of Withdrawn Drugs to Prevent Pharmacy Compounding April 27, 2023
Letters, Testimony & Filings Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe or Ineffective to Include Hydroxyprogesterone Caproate for Prevention of Preterm Birth April 27, 2023
Testimony Before the FDA’s Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee Regarding Brexpiprazole April 14, 2023