fbpx
March 8, 2021

FDA Authorizes First Molecular At-Home, OTC COVID-19 Test FDA Authorizes First Molecular At-Home, OTC COVID-19 Test

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) […]
March 8, 2021

Tocilizumab Scores FDA Approval for SSc-ILD Tocilizumab Scores FDA Approval for SSc-ILD

The Food and Drug Administration has approved subcutaneously-injected tocilizumab (Actemra) to reduce the rate of pulmonary function decline in systemic sclerosis–associated interstitial lung disease (SSc-ILD) patients, […]
March 5, 2021

Fever Scanners for COVID-19 May Be Inaccurate, FDA Warns Fever Scanners for COVID-19 May Be Inaccurate, FDA Warns

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center. The US Food and Drug Administration (FDA) has issued an alert to […]
March 3, 2021

Adalimumab Earns FDA Approval for Ulcerative Colitis in Children Adalimumab Earns FDA Approval for Ulcerative Colitis in Children

Adalimumab has received approval from the Food and Drug Administration for use in pediatric patients aged 5 years and older with moderately to severely active ulcerative […]
March 1, 2021

FDA: Recall of Medtronic HVAD Implant Kits Is Class 1 FDA: Recall of Medtronic HVAD Implant Kits Is Class 1

A recall of implant kits for the HeartWare Ventricular Assist Device (HVAD), initiated by Medtronic in November 2020, has been declared Class I by the US Food […]
March 1, 2021

First Oral SMA Treatment Gets EMA Panel Thumbs Up First Oral SMA Treatment Gets EMA Panel Thumbs Up

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for risdiplam (Evrysdi), the first treatment that […]
February 27, 2021

FDA Grants Emergency Use to Johnson & Johnson COVID-19 Vaccine FDA Grants Emergency Use to Johnson & Johnson COVID-19 Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. And then there were three. The US Food and Drug Administration (FDA) […]
February 25, 2021

FDA OKs First ‘Targeted Treatment’ for Rare DMD Mutation FDA OKs First ‘Targeted Treatment’ for Rare DMD Mutation

The US Food and Drug Administration (FDA) has approved the antisense oligonucleotide casimersen (Amondys 45, Sarepta Therapeutics) injection for the treatment of patients with Duchenne muscular […]
February 20, 2021

FDA Warns About Potential Inaccuracies With Pulse Oximeters FDA Warns About Potential Inaccuracies With Pulse Oximeters

Pulse oximeters have become popular during the COVID-19 pandemic for people to track their oxygen saturation, but they may not always be accurate, the FDA cautioned […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0