Regulatory
The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.
The FDA has lifted the clinical hold it had placed on the Phase Ib study following the occurrence of hematological malignancies.
Acadia Pharmaceuticals announced the approval of Daybue (trofinetide) as the first and only drug to treat Rett Syndrome, a rare, neurodegenerative disorder affecting primarily girls.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.
With the results from the CLEAR outcomes study, Esperion is poised for a major inflection in sales and is targeting blockbuster status, said CEO Sheldon Koenig on an investor call Monday.
The FDA’s Oncologic Drugs Advisory Committee will meet March 9 to discuss Roche’s sBLA for Polivy in first-line DLBCL, while Acadia awaits potential approval of the first therapy for Rett Syndrome.
In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.
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