Tag: fda

Time to Move Away From Using Decontaminated Respirators

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) today recommended that healthcare...

FDA Approves First AI Device to Detect Colon Lesions

The US Food and Drug Administration (FDA) on Friday announced its first-ever approval of an artificial intelligence device to help find colon lesions during colonoscopy....

OCS Heart System Earns Hard-Won Backing of FDA Panel

After more than 10 hours of intense debate, a US Food and Drug Administration (FDA) advisory panel gave its support to a premarket approval application...

Deaths Tied to Reprocessed Urologic Endoscopes, FDA Warns

The US Food and Drug Administration (FDA) is warning healthcare providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing...

Rapid COVID Tests Are Coming to Stores Near You

  Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Scientists and lawmakers agree that over-the-counter covid tests could allow...

US authorization of AstraZeneca vaccine could come in April: Official

Results of AstraZeneca Plc’s U.S. COVID-19 vaccine trial are being reviewed by independent monitors, and emergency authorization could come in about a month, a top...

Benefits of Drug for Women With Hyposexual Disorder Questioned

Bremelanotide, a Food and Drug Administration–approved treatment for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, may be of limited use, suggests Glen...

To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. President Joe Biden has promised enough covid vaccine to immunize every...

Convenience, Cost, and Some Caveats

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. At-home testing for COVID-19 features great convenience, but pathology experts caution...

Tussle between US, allies over Covid vaccine supply escalates

Millions of coronavirus vaccine doses are in cold storage in the U.S. that can’t be injected in the states because they are not yet approved...

Pfizer’s Vaccine Plant Has History of Recalls

By Sarah Jane Tribble, Kaiser Health News Wednesday, March 10, 2021 (Kaiser News) — Pfizer’s management knew last year there was “a mold issue” at...

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...

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...

Cancer Drugmaker Destroyed Records Before FDA Inspection

A company that manufacturer ingredients for cancer drugs used in the United States has pleaded guilty to concealing and destroying records prior to an inspection...

Biden Vows Enough COVID-19 Vaccine for Every Adult by End of May

March 2, 2021 — President Joe Biden on Tuesday said the United States will have enough COVID-19 vaccine doses to inoculate every American adult by May. In...

3.9 million J&J COVID Shots to Ship, More Expected Soon

The federal government is shipping 3.9 million doses of Johnson and Johnson’s COVID-19 vaccine starting today, just days after the FDA granted the shot emergency...

Peanut Sublingual Immunotherapy Feasible and Effective in Toddlers

Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year. In a double-blind, placebo-controlled,...

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 Clears Device to Protect Kids Against Head Injury

The US Food and Drug Administration (FDA) has cleared a new over-the-counter device designed to protect children aged 13 years and older from sports-related traumatic...

J&J COVID-19 Vaccine Wins Backing of FDA Panel

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. An FDA advisory panel lent their support today to a rapid...

Promising Treatments for Molluscum Contagiosum and Acne

No Food and Drug Administration–approved treatment currently exists for molluscum contagiosum, which affects an estimated 6 million people in the United States, but that could...

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...

US Cancer Drug Approvals Ensure Access but Not Value

Cancer drugs that have been approved in the United States are often not immediately approved in the United Kingdom and Canada, owing to uncertainty over...

FDA Approves Cemiplimab-rwlc for NSCLC With PD-L1 Expression

The US Food and Drug Administration (FDA) has approved cemiplimab-rwlc (Libtayo) for the treatment of advanced non–small cell lung cancer (NSCLC). Specifically, the indication is...

Expect Steady Rise in US Supply

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The United States might possibly have a surplus of COVID-19 vaccines...