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FDA: Initial Review Shows No Clear Link Between GLP-1 RAs and Suicidal Ideation

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. ....

Drug Administration , Event Reporting ,

FDA: Initial Review Shows No Clear Link Between GLP-1 RAs and Suicidal Ideation

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. ....

Drug Administration , Event Reporting ,

Practical Toxicity Management Awareness With FGFR Inhibitors Improves Real-World Patient Outcomes

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. ....

United States , Srdan Verstovsek , Vivek Subbiah , University Of Texas Md Anderson Cancer Center , Clinical Center , Division Of Cancer Medicine , Targeted Therapy , Cancer Medicine , Cancer Center , Event Reporting , Precision Medicine In Oncology ,

FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

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. ....

United States , Jim Jones , Peter Marks , Drug Administration , Human Services , Infinant Health Inc , Us Department Of Health , Biosystems Inc , Public Health Service , For Immediate Release , Biologics License Application , Investigational New Drug , Biologics Evaluation , Abbott Laboratories , Similac Probiotic Tri Blend , Federal Food , Cosmetic Act , Infinant Health , Evolve Biosystems Inc , Event Reporting ,

FDA issues formal warning about probiotics for preterm infants

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. ....

United States , Mead Johnson , Peter Marks , Infinant Health Inc , Drug Administration , University Of California Davis , Oregon State University , Infinant Health , California Davis , Biologics Evaluation , Like Infinant , Similac Probiotic Tri Blend , Event Reporting ,