Regulatory
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.
The FDA is expected to cap off February with a trio of verdicts, including one for a heart failure treatment and another potential first approval for a rare, neurodegenerative disease.
The FDA accepted the BLA for and granted Pfizer’s maternal RSV vaccine candidate priority review.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease.
If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
Taxpayer-funded research in biosciences will no longer sit behind paywalls. Instead, all of this data will be publicly available for no cost.
The FDA has rejected Soligenix’s NDA for HyBryte (synthetic hypericin), a therapeutic developed to treat early-stage cutaneous T-cell lymphoma.
The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities in its Helicobacter pylori drug products.
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