Experimental Alzheimer’s Drug Slows Decline in Thinking in Late-Stage Trial
WEDNESDAY, May 3, 2023 (HealthDay News) — Another experimental drug meant for Alzheimer’s disease looks so promising that drugmaker Eli Lilly plans to ask the U.S. Food and Drug Administration for full approval by the end of June. Known as donanemab,…
Learn MoreFDA Approves First Pill for Fecal Transplant Therapy
THURSDAY, April 27, 2023 (HealthDay News) — The U.S. Food and Drug Administration on Wednesday approved the first pill form of fecal microbiota — similar to what is known as fecal transplant therapy — to treat Clostridioides difficile.The drug, Vow…
Learn MoreFDA Approves Drug for Rare Form of ALS
WEDNESDAY, April 26, 2023 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday approved a new drug for people who have a rare, inherited type of amyotrophic lateral sclerosis (ALS). The medication, Qalsody (tofersen), targets a mutatio…
Learn MoreFDA Approves Cord Blood Stem Cell Product for Blood Cancer Patients
MONDAY, April 24, 2023 (HealthDay News) — The U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy, to cut the risk of infection in patients with blood cancer followi…
Learn MoreFDA Approves First Over-the-Counter Nasal Spray for Opioid Overdoses
WEDNESDAY, March 29, 2023 (HealthDay News) — The U.S. Food and Drug Administration on Wednesday approved the over-the-counter (OTC) use of naloxone (Narcan).”Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase …
Learn MoreFDA Approves First Treatment for Rett Syndrome
TUESDAY, March 14, 2023 (HealthDay News) – The U.S. Food and Drug Administration has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients aged 2 years and older.Approval was based on results from the phase 3…
Learn MoreNew Nasal Spray for Migraines Approved by FDA
MONDAY, March 13, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Pfizer’s zavegepant (Zavzpret), a calcitonin gene-related peptide receptor antagonist nasal spray meant to treat severe headache pain, the company announced …
Learn MoreFDA Approves First Home Test to Detect Both Flu and COVID-19
MONDAY, Feb. 27, 2023 (HealthDay News) — A new at-home test will help people struggling with upper respiratory symptoms figure out whether they have COVID-19 or the flu. The U.S. Food and Drug Administration approved Lucira under an emergency use aut…
Learn MoreFDA Approves First Treatment for Geographic Atrophy
FRIDAY, Feb. 24, 2023 (HealthDay News) — Pegcetacoplan (SYFOVRE) has been approved by the U.S. Food and Drug Administration as the first and only treatment for geographic atrophy (GA), an advanced form of age-related macular degeneration.Pegcetacopl…
Learn More10 Percent of New Drugs Approved Without Meeting Primary Efficacy End Points
TUESDAY, Feb. 14, 2023 (HealthDay News) — From 2018 to 2021, 10 percent of drugs approved by the U.S. Food and Drug Administration were based on pivotal studies with null findings for one or more primary efficacy end points, according to a research l…
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