Tag: Drug Approvals
FDA Approves First RSV Vaccine
Arexvy was ~82 percent effective in preventing RSV-induced lower respiratory tract infections in adults 60 years of age and older
FDA Approves First Pill for Fecal Transplant Therapy
Vowst is approved to prevent recurrence of C. difficile; pill contains live gut bacteria from stool samples donated by healthy people
FDA Approves Drug for Rare Form of ALS
Agency approved the drug based on evidence of a reduction in plasma neurofilament light; no evidence the drug slowed the disease
FDA Approves Cord Blood Stem Cell Product for Blood Cancer Patients
Omisirge speeds neutrophil recovery and cuts risk of infection
FDA Approves First Over-the-Counter Nasal Spray for Opioid Overdoses
The spray can already be obtained without a prescription, but currently buyers must get it from a pharmacist
FDA Approves First Treatment for Rett Syndrome
Approval of Daybue applies to adults and children aged 2 years and older
New Nasal Spray for Migraines Approved by FDA
About 40 percent of trial participants who took the medication were free of their worst symptoms two hours after using the medication
FDA Approves First Home Test to Detect Both Flu and COVID-19
Test will be sold without a prescription and can be used by anyone 14 years and older or by an adult on children ages 2 years and older
FDA Approves First Treatment for Geographic Atrophy
Pegcetacoplan approved as an injection with dosing every 25 to 60 days
10 Percent of New Drugs Approved Without Meeting Primary Efficacy End Points
Findings seen for 21 drug approvals between 2018 and 2021, with only one-third needing postmarketing studies
