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April 2, 2024
The latest round of revisions to Form PF made a stealthy arrival, with the SEC announcing in mid-February that it adopted the updates without an in-person vote. As the...
February 21, 2024
The Food and Drug Administration (“FDA”) will begin enforcement of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) on July 1, 2024. MoCRA represents the biggest...
January 12, 2024
The FDA has issued an update regarding the ongoing evaluation of reports of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists.
January 11, 2024
The FDA has issued an update regarding the ongoing evaluation of reports of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists.
January 8, 2024
Vivek Subbiah, MD, emphasizes the need for improved guidance on practical toxicity management for various FGFR-altered malignancies, highlights best practices for monitoring and managing the most common on-target toxicities associated with FGFR inhibitors, and discusses the key implications of this review for those utilizing FGFR inhibitors.
October 26, 2023
The agency is advising the public, including healthcare providers, of the possible risks that products containing live bacteria or yeast, which are commonly called probiotics, pose to preterm infants in hospital settings.
October 26, 2023
FDA has posted a formal warning today about the use of probiotics with preterm infants. The notice went up after a second warning letter was sent to a company marketing a probiotic product for that use.
October 16, 2023
In May 2023, the SEC adopted amendments to Form PF, which change certain existing questions and create new events-based reporting requirements.