Indian Drugmaker Granules to Tighten Oversight After US FDA Warning
Indian drugmaker Granules plans to tighten its oversight processes after receiving a warning from the US FDA, according to an executive.
Results for "US FDA"
18 stories found
US FDA Approves Novo's Insulin Injection for Type 2 Diabetes
The U.S. Food and Drug Administration has approved Novo Nordisk's insulin injection for the treatment of type 2 diabetes. This approval marks a new development in diabetes management.
GSK granted FDA nod for Lynavoy for itch associated with rare liver disorder
US FDA declines to approve Aldeyra's eye disorder drug, shares slump - Reuters
US FDA declines to approve Aldeyra's eye disorder drug, shares slump Reuters
US FDA's operations chief to retire, 30-year agency veteran to succeed - TradingView
US FDA's operations chief to retire, 30-year agency veteran to succeed TradingView
US FDA approves Eton's liquid therapy for rare water-balance disorder - Reuters
US FDA approves Eton's liquid therapy for rare water-balance disorder Reuters
US FDA Warns of Liver Injury Cases Linked to Amgen Drug
The US FDA has issued a warning regarding cases of liver injury associated with a rare disease drug manufactured by Amgen.
US FDA Approves Denali's Genetic Disorder Therapy for Children
The U.S. Food and Drug Administration (FDA) has granted approval for Denali Therapeutics' new therapy designed to treat a genetic disorder in children.
Aurobindo Pharma's Rajasthan Unit Classified OAI by US FDA
A unit of Aurobindo Pharma's arm in Rajasthan, India, has been classified as 'Official Action Indicated' (OAI) by the U.S. Food and Drug Administration.
Novo Nordisk Receives Warning Letter from US FDA Regarding Side Effect Reporting
Novo Nordisk has reportedly violated reporting protocols for potential side effects, according to the US Food and Drug Administration.
US FDA warns Novo again about misleading drug advertising - Reuters
US FDA warns Novo again about misleading drug advertising Reuters
US FDA approves Vanda's antipsychotic pill, shares climb - Reuters
US FDA approves Vanda's antipsychotic pill, shares climb Reuters
Novo Nordisk Wins US FDA Approval for Once-Weekly Insulin Awiqli for Type 2 Diabetes
Novo Nordisk has secured US FDA approval for its once-weekly insulin Awiqli, expanding its presence in diabetes care and offering a new treatment option for type 2 diabetes.
US FDA approves higher dose of Novo's Wegovy under new fast-track review program - Reuters
US FDA approves higher dose of Novo's Wegovy under new fast-track review program Reuters
FDA approves psoriasis pill from J&J that rivals shots Tremfya, Skyrizi
Johnson & Johnson said the U.S. Food and Drug Administration approved its once-daily psoriasis pill, the first oral option to rival best-selling shots.
US FDA approves Johnson & Johnson's blood cancer drug after speedy review - Reuters
US FDA approves Johnson & Johnson's blood cancer drug after speedy review Reuters
US FDA warns 30 telehealth firms over misleading ads for compounded weight‑loss drugs - Reuters
US FDA warns 30 telehealth firms over misleading ads for compounded weight‑loss drugs Reuters
FDA Reverses Course, Agrees to Review Moderna's Flu Vaccine Application
The U.S. Food and Drug Administration has reversed its earlier decision and will now review Moderna's application for its modified influenza vaccine.