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Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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Rivus Pharmaceuticals will push HU6 into Phase III development and is looking to engage with regulatory authorities and launch a late-stage study next year in obesity-related heart failure with preserved ejection fraction.
Plus, learn how to handle vacation time in a new job and navigate the stress of a recent promotion to leadership.
Lykos Therapeutics will ask the FDA to reconsider its rejection of the company’s MDMA-assisted PTSD therapy, Pfizer scores positive Phase III results for its RSV vaccine, a roundup of Q2 earnings season and more.
On the heels of last week’s FDA rejection of Lykos’ MDMA-assisted PTSD therapy, Atai announced Tuesday positive preliminary results for its DMT-based treatment for depression from a Phase Ib study.
While some biopharma companies beat expectations, others fell short for various reasons, with some deciding to return or axe assets.
The layoffs are intended to help provide an operating runway into the fourth quarter of 2026.
The Swiss company’s monoclonal antibody Nemluvio is also undergoing regulatory review for atopic dermatitis, which is a potentially larger market for the first-in-class IL-31 blocker.
On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.
By the end of the year, Novo Nordisk intends to make a regulatory filing for the combination of its icodec and semaglutide, keeping its once-weekly insulin program afloat.
The acquisition announced Monday will give Crown access to Revance’s Daxxify, a competitor to AbbVie’s Botox, which is indicated for frown lines and for cervical dystonia.