FDA Approves OXBRYTA (Voxelotor) for the Treatment of Sickle Cell Disease in Adults and Pediatric Patients 12 Years of Age and Older
FDA Approves XCOPRI (Cenobamate) for Partial-Onset Seizures in Adult Patients
FDA Approves FETROJA (Cefiderocol) for the Treatment of Complicated Urinary Tract Infections in Patients 18 Years of age or Older
FDA Approves ADAKVEO (Crizanlizumab-tmca) to Reduce the Frequency of Vasoocclusive Crises in Adults and Pediatric Patients Aged 16 Years and Older with Sickle Cell Disease
FDA Approves SCENESSE (Afamelanotide) Implant to Increase Pain Free Light Exposure in Adult Patients with a History of Phototoxic Reactions from Erythropoietic Protoporphyria
FDA Approves INREBIC (fedratinib) for Myelofibrosis
FDA Approves XENLETA (Lefamulin) Injection and Tablets for the Treatment of Adults with Community-Acquired Bacterial Pneumonia (CABP)
FDA Approved ROZLYTREK for ROS1-Positive Non-Small Cell Lung Cancer in Adults and Pediatric Patients 12 Years and Older
FDA Approves WAKIX for Excessive Daytime Sleepiness (EDS) in Adults with Narcolepsy
FDA Announces Availability of the Draft Guidance “Population Pharmacokinetics”
FDA Approves TURALIO (Pexidartinib) for Treatment of Adult Patients with Symptomatic Tenosynovial Giant Cell Tumor Associated with Severe Morbidity
FDA Announces Availability of the Draft Guidance, “M10 Bioanalytical Method Validation”
FDA Approves CORLANOR (Ivabradine) Oral Solution to Reduce the Risk of Hospitalization for Worsening Heart Failure in Adult Patients with Chronic Heart Failure
FDA Announces Availability of a Final Guidance, “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations”
FDA Approves SKYRIZI for the Treatment of Moderate-to-Severe Plaque Psoriasis in Adults who are Candidates for Systemic Therapy or Phototherapy
FDA Approves MAYZENT for the Treatment of Relapsing Forms of Multiple Sclerosis
FDA Approves SPRAVATO with an Oral Antidepressant for the Treatment of TRD in Adults
FDA Approves ZULRESSO for Postpartum Depression in Adults
Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations
Bioavailability Studies Submitted in NDAs or INDs — General Considerations
FDA Approves EGATEN (Triclabendazole) for Fascioliasis in Patients 6 Years of Age or Older
FDA Approves ULTOMIRIS (Ravulizumab-cwvz) for Adult Patients with Paroxysmal Nocturnal Hemoglobinuria