A phase 3 trial evaluating rolfumilast cream 0.05% in children with mild to moderate atopic dermatitis met its primary and all secondary endpoints.
Updated COVID-19 vaccines from Pfizer-BioNTech and Moderna have now been approved and authorized for emergency use.
Novartis has voluntarily recalled 1 lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to crystal formation.
The labeling for StrataGraft has been updated to reflect the FDA’s determination that several xenotransplantation-related requirements are no longer necessary.
AbbVie has submitted a regulatory application to the FDA seeking approval of risankizumab for the treatment of adults with moderately to severely active ulcerative colitis.
Hepzato Kit™ (melphalan/Hepatic Delivery System) is approved as a liver-directed treatment for adults with metastatic uveal melanoma with unresectable hepatic metastases.
The FDA has approved Ycanth (cantharidin) topical solution for the treatment of molluscum contagiosum in patients 2 years of age and older.
The phase 3 VAPAUS study evaluated QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of adults with pachyonychia congenita.
The FDA has granted Fast Track designation to STAR-0215 for the treatment of hereditary angioedema.
Positive topline results were announced from a phase 3 trial evaluating ruxolitinib cream in pediatric patients with atopic dermatitis.
Several biosimilar products to Humira® (adalimumab), a tumor necrosis factor (TNF) blocker, have now been made commercially available.
The full data set from the FORMULA-OLS study will be submitted as part of the revised NDA.
The FDA has extended the review period for neffy (intranasal epinephrine) for the treatment of severe allergic reactions, including anaphylaxis.
Treatment with reproxalap 0.25% ophthalmic solution led to statistically significant improvements in patients with allergic conjunctivitis.
Brixadi is supplied as prefilled single-dose syringes in weekly (8 mg,16 mg, 24 mg, 32 mg) and monthly (64 mg, 96 mg,128 mg) doses.
Researchers report on the FDA’s approval of Abrysvo for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
Researchers report that the FDA has accepted for Priority Review the Biologics License Application for lifileucel, a 1-time cell therapy, for advanced melanoma.
Researchers report on the FDA approval of Yuflyma.
Vyjuvek is a topical HSV-1 vector-based gene therapy.
Consumers are being advised to stop using the Walnut Wearable Smart Thermometer immediately.
Caldolor contains ibuprofen, a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties.
Arexvy is expected to be available for the 2023-2024 RSV season.
Akorn ceased and shutdown all operations following a Chapter 7 bankruptcy filed on February 23, 2023.
Resilia Pharmaceuticals has announced the relaunch of Solace Cream for the treatment of signs and symptoms of eczema.
Brella is a single-use disposable patch consisting of a sodium sheet with an adhesive overlay that is applied to a patient’s underarm by a health care provider for up to 3 minutes.
Approval of the modified Opioid Analgesic REMS is expected in 2024.
Zosyn premix is supplied in 2.25 g in 50 mL, 3.375 g in 50 mL, and 4.5 g in 100 mL presentations.
Treatment with dupilumab led to a significant 30% reduction in moderate or severe acute COPD exacerbations.
Narcan Nasal Spray for OTC use is expected to be available by late summer and will have the same formulation, device design, and 4 mg strength as the prescription product.
Retifanlimab is a programmed death receptor-1-blocking antibody.
