Vertex doesn’t need to do any more safety studies to identify potential off-target effects for exa-cel (exagamglogene autotemcel), its investigational gene-editing therapy designed to cure sickle cell disease, an FDA…
Despite missing its pivotal phase 3 primary efficacy endpoint, Sarepta is sailing confidently into a supplemental application to remove the age limitation on Elevidys (delandistrogene moxeparvovec-rokl), its gene therapy for…
CBER has launched an online crowdsourcing campaign that asks stakeholders what they see as the major advances in biological product development likely to emerge in the next three to ten…
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as the 18th Annual Inspections vSummit from FDAnews, a WCG company, and webinars on how to…
A new FDA guidance set to take effect immediately extends the agency’s COVID-era policies requiring supplementary submissions for certain modifications to a device approved under the premarket approval (PMA) or…
Nostrum Laboratories and its CEO have struck a potential $50 million settlement with the Department of Justice (DOJ) to resolve allegations the company knowingly underpaid Medicaid rebates for its Nitrofurantoin…
In this edition of Quick Notes, we cover medical device clearances for GE HealthCare’s Allia IGS Pulse for cardiac imaging, Ventric Health’s Vivio system for heart failure diagnosis, the Ori…
In an agreement worth up to $600 million, Eli Lilly will acquire Beam Therapeutics’ opt-in rights to three of Verve Therapeutics’ cardiovascular disease gene-editing programs in exchange for cash, potential…
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation recently released a report focusing on how the FDA can…
Although Medicare will now cover antiamyloid antibodies fully approved for early Alzheimer’s and the PET imaging required to qualify for them, questions remain about how coverage will shake out for…