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Ceribell has received 510(k) clearance from the U.S. Food and Drug Administration for its updated Clarity algorithm, which enables the detection of electrographic seizures in both preterm infants and adult patients.
According to the company, this authorization marks the first FDA-cleared artificial intelligence–supported electroenc...
Imfinzi by AstraZeneca is already on the list of achievements in the category of perioperative labels, and the new FDA label provides the drug with the name of the first and only immunotherapy to address the needs of patients with stomach cancer at the initial stage, before and after the surgery.
Imfinzi may also be given together with s...
Novo Nordisk is moving ahead with late-stage development of amycretin after mid-stage clinical results in people with Type 2 diabetes. The shift represents a change from earlier plans, when the drug was viewed primarily as an obesity candidate. The company now intends to begin phase 3 studies in Type 2 diabetes next year.
The updated str...
Novartis has outlined several updates to its manufacturing network that include job reductions in Switzerland and expanded investment in the United States. The announcement follows the company’s recent disclosure of plans to create a new manufacturing hub in North Carolina that would add 700 positions.
In northern Switzerland, Novartis p...
Novartis has secured FDA approval for Itvisma, an updated version of its gene therapy Zolgensma, extending treatment to older patients with spinal muscular atrophy (SMA).
More than six years after Zolgensma was first cleared for children under 2, Itvisma’s label now encompasses older individuals with a confirmed SMN1 gene mutation.</span...
