FDA Approves VIVJOA (Oteseconazole) to Reduce the Incidence of Recurrent Vulvovaginal Candidiasis (RVVC) in Females with a History of RVVC who are Not of Reproductive Potential
FDA Announces Availability of a Draft Guidance, Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
FDA Announces Availability of a Final Guidance Entitled Bioavailability Studies Submitted in NDAs or INDs - General Considerations
FDA Approves VIJOICE (Alpelisib) for the Treatment of Adult and Pediatric Patients 2 Years of Age and Older with Severe Manifestations of PROS
FDA Announces Availability of a Draft Guidance Entitled Clinical Pharmacology Considerations for Antibody-Drug Conjugates
FDA Approves KIMMTRAK for the Treatment of HLA-A*02:01-Positive Adult Patients with Unresectable or Metastatic Uveal Melanoma
FDA Announces Availability of a Draft Guidance Entitled "Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format"
FDA Announces Availability of a Final Guidance Entitled Population Pharmacokinetics
FDA Designates a New Bayesian Optimal Interval Design as ‘Fit-For-Purpose’ Under Certain Conditions as a Statistical Methodology for Phase 1 Dose-Finding Clinical Trials