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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 announces nationwide cheese recall over E. coli outbreak▼FDA announces nationwide cheese recall after E. coli outbreak
The US Food and Drug Administration has announced a nationwide recall of cheese linked to an E. coli outbreak. The recall covers products distributed across the country, and consumers are being urged to check their purchases. Details on the brands affected and reported illnesses have not yet been fully disclosed.
- 3FDA 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.
- 4
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.
- 5
The US Food and Drug Administration has issued draft guidance for surgical robots, outlining its thinking for developers and manufacturers of robotic surgical systems.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.
- 6FDA Issues Draft Guidance for Cardiovascular Surgical Robots▼FDA shares draft guidance for cardiovascular surgical robots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.
- 7AbbVie 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.
- 8FDA 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.