search
Food and Drug Administration
Trends
- 1
The US Food and Drug Administration has released draft guidance covering surgical robotics. The document, reported by MedTech Dive, outlines the agency's current thinking for developers and manufacturers of robotic surgical systems. Stakeholders in the medical device industry typically have the opportunity to comment on such drafts before final guidance is issued, which shapes approval expectations for robot-assisted surgery technologies.
- 2Israeli startup wins FDA clearance for injection-based diabetes app▼Israeli startup develops injection-based diabetes app, receives FDA clearance
An Israeli startup has received US Food and Drug Administration clearance for an app designed to support people managing diabetes with injections. The digital tool is aimed at helping patients track and handle their insulin treatment more effectively. The clearance marks a regulatory milestone for the young company, and coverage in Israeli media highlights it as another example of the country's health-tech sector gaining traction abroad.
- 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.
- 5Former FDA chief says cyclosporiasis outbreak not fully under control●Cyclosporiasis outbreak not 'fully under control,' former FDA chief says
A former head of the US Food and Drug Administration has warned that the ongoing cyclosporiasis outbreak in the United States is not 'fully under control,' despite official responses. The intestinal illness, typically linked to contaminated produce, has been the subject of public health tracking, and the comment raises concerns about the effectiveness of containment efforts so far.