FDA Approves Nivolumab as Adjuvant Treatment for Melanoma
WEDNESDAY, Oct. 18, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Opdivo (nivolumab) for the adjuvant treatment of completely resected stage IIB/C melanoma in patients ages 12 years and older.The approval was based on res…
Learn MoreFDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults
TUESDAY, Oct. 17, 2023 (HealthDay News) — The U.S. Food and Drug Administration approved Velsipity (etrasimod) for adults with moderately to severely active ulcerative colitis (UC).The approval was based on results from the ELEVATE UC phase 3 registr…
Learn MoreFDA Approves Updated Novavax COVID-19 Vaccine
WEDNESDAY, Oct. 4, 2023 (HealthDay News) — Federal regulators on Tuesday gave the go-ahead to an updated Novavax COVID-19 vaccine, giving Americans a more traditional alternative to two recently revamped mRNA vaccines.Adolescents and adults who have …
Learn MoreEven Five Years Postapproval, Many Drug Studies Remain Nonpublic
FRIDAY, Sept. 1, 2023 (HealthDay News) — Only a fraction of evidence from completed studies is available publicly before drugs receive U.S. Food and Drug Administration approval, according to a study published in the August issue of Health Affairs Sc…
Learn MoreFirst Biosimilar Approved to Treat Multiple Sclerosis
FRIDAY, Aug. 25, 2023 (HealthDay News) — The U.S. Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announc…
Learn MoreFDA Approves Akeega for BRCA-Positive Metastatic Prostate Cancer
THURSDAY, Aug. 17, 2023 (HealthDay News) — The U.S. Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer.The approval makes Akeega the fi…
Learn MoreFDA Provides Accelerated Approval of Talvey for Multiple Myeloma
TUESDAY, Aug. 15, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Talvey (talquetamab-tvgs) for patients with relapsed or refractory multiple myeloma.The accelerated approval is for individuals who have received at least fo…
Learn MoreFDA Approves Izervay for Geographic Atrophy Tied to Age-Related Macular Degeneration
WEDNESDAY, Aug. 9, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration.The approval was ba…
Learn MoreFDA Gives Approval to Pill to Ease Postpartum Depression
MONDAY, Aug. 7, 2023 (HealthDay News) — The U.S. Food and Drug Administration on Friday approved a new pill, called Zurzuvae (zuranolone), that may quickly ease severe postpartum depression and help millions of women regain their emotional equilibriu…
Learn MoreFDA Approves Xdemvy for Demodex Blepharitis
FRIDAY, July 28, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Xdemvy (lotilaner ophthalmic solution) 0.25 percent for the treatment of Demodex blepharitis, caused by Demodex mites.The approval was based on results from t…
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