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Food and Drug Administration
Trends
- 1Blood pressure medication recalled nationwide under FDA Class II risk●Blood pressure medication recalled nationwide under FDA’s Class II risk level
A blood pressure medication has been recalled across the United States, with the Food and Drug Administration classifying the action as a Class II risk level recall. Class II means the product may cause temporary or medically reversible health consequences, but the chance of serious harm is remote. Further details about the drug, manufacturer and reason for the recall have not yet been widely reported.
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The US Food and Drug Administration has released draft guidance for surgical robots, setting out proposed recommendations for devices used in robotic-assisted surgery. The guidance, reported by MedTech Dive, gives manufacturers and healthcare providers a framework to review. Stakeholders can weigh in before the agency finalizes its position.
- 3FDA approves AbbVie's Parkinson's drug from Cerevel deal●AbbVie wins FDA approval for Parkinson’s drug from $8.7B Cerevel takeover
AbbVie has won US Food and Drug Administration approval for a Parkinson's disease treatment developed through its $8.7 billion acquisition of Cerevel Therapeutics. The approval validates the company's large bet on neurology and gives AbbVie a new product in a market where its flagship franchise faces eventual competition. Industry observers are watching how quickly the drug can reach patients and generate revenue.
- 4AbbVie wins FDA approval for new Parkinson's drug Juvmo●AbbVie lands FDA approval for next-generation Parkinson’s drug, Juvmo
AbbVie has received US Food and Drug Administration approval for Juvmo, described as a next-generation treatment for Parkinson's disease. The decision adds a new option to AbbVie's neurology portfolio and gives patients and doctors an additional therapy for managing the progressive movement disorder.