FDA advisory panel votes unanimously against J&J heart shunt
Panelists focused on study data that showed the implant did not improve outcomes in heart failure patients.
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Aetna updates on prior authorization reform
The CVS-owned payer is working to bundle multiple prior authorizations for certain conditions into one single review.
HHS outlines strategy to expand AI adoption
Although the strategy is internally focused to start, the agency said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools.
In Change That Pushed Pazdur Out, FDA May Lower Clinical Trial Requirements
Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies seeking approval for new drugs.
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FDA Pauses Denali’s Pompe Plans Due to Preclinical Safety Signals
Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 for Pompe disease.
FDA Pauses Denali’s Pompe Plans Due to Preclinical Safety Signals Read More »
CDC’s Vaccine Advisers Again Delay Hep B Vote
The ACIP decided 6–3 to postpone its vote on hepatitis B vaccination changes after the language of the questions was repeatedly changed in the days leading up to the meeting.
Praxis Ends Epilepsy Study Early Due to Strong Results, Heads to FDA
Praxis has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug candidate ulixacaltamide, for which an approval application is slated for early 2026.
Praxis Ends Epilepsy Study Early Due to Strong Results, Heads to FDA Read More »
Captura más barata y simple de dióxido de carbono del aire
El exceso de dióxido de carbono en el aire es culpable del calentamiento global que él clima de la Tierra está experimentando. Aparte de reducir la emisión de este gas de efecto invernadero a la atmósfera, también existe la opción de retirarlo de ella …
Captura más barata y simple de dióxido de carbono del aire Read More »
El misterio del cinturón de radiación de Urano
Un nuevo estudio puede haber resuelto un enigma sobre Urano con el que se topó la nave Voyager 2 hace cuatro décadas. En enero de 1986, cuando la sonda espacial Voyager 2 de la NASA hizo la primera y por ahora única visita de la historia de la astronáutica a este …
Más misterio sobre cómo se organizó la construcción de las enigmáticas estatuas de la isla de Pascua
La isla de Pascua o Rapa Nui, es famosa por sus cientos de peculiares estatuas de piedra (moais) esculpidas por comunidades polinesias sobre todo durante una época que comenzó en el siglo XIII y acabó en el XVI. Parece lógico suponer, como así se ha venido …