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...
FDA joins the United States Pharmacopeia and the Association for Accessible Medicines next month for a public workshop focused on how compendial stand...
Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the agency intends to adopt oversight of generative arti...
