US FDA Warns of Liver Injury Cases Linked to Amgen’s Rare Disease Drug
The US Food and Drug Administration (FDA) has reported cases of liver injury in patients treated with Amgen’s drug Tavneos […]
US-FDA
US FDA Expected to Lift Restrictions on Certain Peptides
The US Food and Drug Administration (FDA) is expected to lift restrictions on certain injectable peptides, which would allow compounding […]
US FDA Approves Leucovorin for Rare Genetic Disorder Causing Autism-Like Symptoms
The US Food and Drug Administration (FDA) has approved leucovorin for the treatment of cerebral folate deficiency (CFD), a rare […]
Aurobindo Pharma Completes US FDA Inspection at Eugia Unit-I with Four Observations
Aurobindo Pharma Limited announced the completion of a United States Food and Drug Administration (US FDA) inspection at Unit-I of […]
US FDA Approves First-Line Use of Boehringer Ingelheim’s Lung Cancer Drug
The US Food and Drug Administration (FDA) has approved the first-line use of Boehringer Ingelheim’s lung cancer therapy zongertinib for […]
US FDA Approves Eton Pharma’s Liquid Therapy for Rare Water-Balance Disorder
The US Food and Drug Administration (FDA) has approved Eton Pharmaceuticals’ liquid therapy Desmoda, an oral solution formulation of desmopressin […]
USFDA brings a new template for non-lab COVID-19 diagnostic test developers
The US Food and Drug Administration (US FDA) released a new template for commercial developers to help them develop and […]
