Tag:
FDA
News
The FDA has approved the new antiviral medication ensitrelvir (Xocova) for the post-exposure prophylaxis of COVID-19
The U.S. Food and Drug Administration (FDA) has approved the new antiviral medication ensitrelvir (Xocova), developed by the Japanese pharmaceutical company Shionogi, for the...
News
Scope of Inhaled Insulin Expands to Pediatric Patients
Managing diabetes in children presents unique challenges that adults rarely face in the same manner. Eating habits in pediatric patients are highly unpredictable; a...
Internal Medicine
The FDA has approved Hepcludex, the first drug for the treatment of chronic hepatitis D
On May 22, 2026, the U.S. Food and Drug Administration (FDA) approved Hepcludex (bulevirtide-gmod) as the first medication for the treatment of chronic hepatitis...
News
The FDA has approved the first gene therapy for hereditary hearing loss
The U.S. Food and Drug Administration (FDA) has officially approved the first gene therapy for the treatment of a rare form of hereditary hearing...
News
The FDA is planning to impose the most serious warning on coronavirus vaccines
The U.S. Food and Drug Administration (FDA) is planning to add the most serious "Black Box" warning to Covid-19 vaccines. This decision, which has...
News
FDA Regulatory Transformation: Accelerated Biosimilar Licensing to Reduce Financial Burden
The U.S. Food and Drug Administration (FDA) has developed a new policy aimed at simplifying the regulatory pathway for biosimilars to accelerate their market...
Internal Medicine
FDA Revokes “Black Box” Warnings for Hormone Replacement Therapy (HRT)
Based on recent research and expert assessments, the U.S. Food and Drug Administration (FDA) has planned strategic changes regarding the labeling of Hormone Replacement...
Internal Medicine
FDA Approves the Third Medication for Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has approved Genentech's intravenous drug Gazyva (Obinutuzumab) for the treatment of active lupus nephritis in adult patients...