In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev.
The first five months of the year showed a slight increase in U.S. FDA approvals, though numbers are down compared to the previous four years. Worldwide approvals are down 16.67% through May, but up 5.42% compared to the previous seven years’ average.
The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend COVID-19 vaccines for the 2023-2024 vaccination campaign be monovalent vaccines that target the XBB variants, currently the most prominent variants of the SARS-CoV-2 virus.
Patients with an aggressive form of lymphoma who have failed prior therapies now have a new option for treatment with the U.S. FDA’s accelerated approval of Columvi (glofitamab-gxbm), which was granted under priority review a few weeks ahead of the July 1 PDUFA date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altamira, Anavex, Avenge, Biostar, Glycomimetics, Ipsen, Mabwell, Medexus, Mersana, NS, Seagen, Takeda, UCB.
General Stim Inc.’s implanted sacral nerve stimulation (SNS) system was approved in China to treat individuals with certain bladder and bowel conditions. Hangzhou-based General Stim’s SNS system consists of a sacral nerve stimulator, an extension lead and an electrode.
The U.S. FDA’s citizen’s petition process doesn’t always yield the desired outcome, but the agency must nonetheless respond to these petitions. Sonex Health Inc., has petitioned the FDA to rethink a proposal to reclassify the company’s SX-One device for treatment of carpal tunnel syndrome, an unusual instance in which a medical device maker has resisted a proposal to make a device exempt from regulatory requirements.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cutera, Vielight.
The French government is officially launching a major national program for digital health. This priority research program and equipment (PEPR) in digital health is being piloted by two major government research bodies, the National Institute for Health and Medical Research (INSERM) and the National Institute for Research in Digital Science and Technology (INRIA). It has a budget of $65 million over seven years
A committee of the U.S. House of Representatives wrapped up business in a late-running June 14 markup of spending bills that would give the U.S. FDA roughly $6.6 billion to work with in fiscal 2024. However, the final bill omits language in the manager’s mark that had called on the FDA to engage in rulemaking or guidance development for lab-developed tests, but the FDA made up for that by adding a proposal to engage in rulemaking for LDTs in its regulatory agenda.
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