FDA qualifies glutamate hydrogenase as a biomarker to enhance liver safety monitoring in clinical trials.
FDA accepts for review an ITM Isotope Technologies NDA for 177Lu-edotreotide (ITM-11), a targeted radiopharmaceutical therapy for gastroenteropancreat...
FDA introduces a new regulatory framework the plausible mechanism pathway designed to speed approval of highly personalized therapies for rare genet...
The CDER Office of Generic Drugs publishes a MAPP to help assessors use the four-part harmony approach in OGD-related communications to applicants.
Alkermes announces that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime sleepiness in patien...
A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Makary, among many oth...
A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therapies.
Cumberland Pharmaceuticals asks FDA to ensure that labeling for generic Acetadote products includes information from the innovator labeling about a tw...
