search
US Food and Drug Administration
Trends
- 1
The US Food and Drug Administration has issued draft guidance for surgical robots, outlining its thinking for developers and manufacturers of robotic surgical systems. The document is expected to shape regulatory expectations in a growing medtech field, and industry stakeholders will likely be able to comment before a final version is adopted.
- 2FDA Issues Draft Guidance for Cardiovascular Surgical Robots▼FDA shares draft guidance for cardiovascular surgical robots
The US Food and Drug Administration has released draft guidance covering cardiovascular surgical robots, outlining its current thinking for developers and manufacturers of these devices. The document, reported by Cardiovascular Business, is expected to shape how robotic systems for heart procedures are designed, tested and cleared. Stakeholders in medical robotics will likely review the draft and submit comments before final guidance is issued.
- 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.