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US Food and Drug Administration
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- 1Former 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.
- 2FDA links Ecuadorian black clams to hepatitis A outbreak▼FDA warns black clams from Ecuador tied to hepatitis A outbreak, 30 hospitalized
The US Food and Drug Administration has warned that black clams imported from Ecuador are linked to a hepatitis A outbreak that has hospitalized 30 people. Health authorities are urging consumers to avoid the shellfish while the investigation continues, and the warning has raised concerns about food safety controls in the seafood import supply chain.
- 3
Reports say the US Food and Drug Administration has approved the first mRNA-based flu vaccine, marking a new application of the technology widely used in COVID-19 vaccines. The trending term reflects news headlines about the decision. Beyond the headline itself, the available posts contain no further details on the vaccine's maker, availability, or public reaction, so what people are saying beyond sharing the news is not clear from the posts.
- 4
The US Food and Drug Administration has released draft guidance covering surgical robotics.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.
- 5Israeli 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.
- 6AbbVie 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.
- 7FDA 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.