Health news
The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application for toripalimab, in combination with gemcitabine and cisplatin, for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal…
The Food and Drug Administration (FDA) has approved Vuity (pilocarpine HCI ophthalmic solution) for the treatment of presbyopia in adults. Vuity is a cholinergic muscarinic receptor agonist designed to improve near and intermediate vision without…
Positive results were announced from a phase 3 study evaluating the long-term efficacy and safety of guselkumab, a selective interleukin (IL)-23 inhibitor, in patients with active psoriatic arthritis. The multicenter, randomized, double-blind, placebo-controlled DISCOVER-2 trial…
The Food and Drug Administration (FDA) has approved the supplemental New Drug Application for Purified Cortrophin® Gel (repository corticotropin injection) for the treatment of certain autoimmune disorders, including but not limited to acute exacerbations of…
Winlevi® (clascoterone cream 1%) is now available for the topical treatment of acne vulgaris in patients 12 years and older. Winlevi, a topical androgen receptor inhibitor, targets androgen receptors at the application site, inhibiting the…
The Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in children 5 to 11 years of age. The FDA’s Vaccines and Related Biological…
Positive results were announced from a phase 3 study evaluating the efficacy and safety of ABBV-951 (foslevodopa/foscarbidopa) in patients with advanced Parkinson disease. ABBV-951 is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous…
A New Drug Application has been submitted to the Food and Drug Administration (FDA) for tebipenem HBr (tebipenem pivoxil hydrobromide) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible microorganisms.…
Individuals fully vaccinated against COVID-19 who have a breakthrough infection can still pass the infection to household contacts, according to new research published in The Lancet Infectious Diseases. The UK study aimed to investigate SARS-CoV-2…
The Food and Drug Administration (FDA) has taken additional steps to strengthen the safety requirements for breast implants. The new FDA order restricts the sale and distribution of breast implants to health care providers and…
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