FDA Related News

Stakeholder Comments on FDA BIMO Guidance

Four stakeholders give FDA general and specific recommendations on a draft guidance on bioresearch monitoring inspection processes and practices.

Human Drugs

Oncologic Drug Dosage Guidance

FDA publishes a guidance on optimizing dosage for oncologic drug and biologic therapies.

Human Drugs

Amneal Gets Approval for Parkinsons Drug

FDA approves an Amneal Pharmaceuticals NDA for Crexont (carbidopa and levodopa) extended-release capsules for treating Parkinsons disease.

Federal Register

Cipro 100mg Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Bayers Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn from sale due to safety...

Federal Register

Drug Experiential Learning Site Visits for FY 2025

Federal Register notice: FDA announces its fiscal year 2025 CDER Office of Pharmaceutical Quality Experiential Learning Site Visit Program.

Human Drugs

Accelerated Approval for Novartis Fabhalta

FDA gives accelerated approval to Novartis Fabhalta for reducing proteinuria in primary IgA nephropathy.

Human Drugs

Huxley Gains Clearance for At-Home Apnea Test

FDA clears a Huxley Medical 510(k) for at-home sleep apnea diagnostic patch, Sansa.

Human Drugs

BCG Treatment Development Guidance

FDA publishes a draft guidance on developing drug and biological treatments for a specific bladder cancer.

Human Drugs

FDA OKs Cutaneous T-cell Lymphoma Therapy

FDA approves a Citius Pharmaceuticals BLA for Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory cutaneous T-cell lymphoma.

Human Drugs

Purdues Opioid-Reversing Injector Approved

FDA approves a Purdue Pharma NDA for Zurnai, a nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose...