Tag: u.s. food and drug administration

CDC Panel Backs Boosters for Seniors, but Not Healthcare Workers

A panel of experts that advises the Centers for Disease Control and Prevention (CDC) on the use of vaccines in the United States has voted...

FDA Approves Cabozantinib for Differentiated Thyroid Cancer

The US Food and Drug Administration (FDA) has approved cabozantinib (Cabometyx) for the treatment of locally advanced or metastatic differentiated thyroid cancer (DTC) in adults...

10 Lessons Learned From the Pandemic, and a Way Forward: Report

The federal government is taking “steps in the right direction” to help control this pandemic, but there have been many hard lessons learned, according to...

FDA Approves Intranasal DHE (Trudhesa) for Acute Migraine

The US Food and Drug Administration (FDA) has approved an intranasal formulation of dihydroergotamine mesylate (DHE) for the acute treatment of migraine with or without...

US Health Officials Warn Booster Shots May Be Limited Initially

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Top federal health officials have told White House officials that the...

FDA Approves First Once-Weekly Growth Hormone for Children

The US Food and Drug Administration (FDA) has approved lonapegsomatropin (Skytrofa, Ascendis Pharma), the first weekly subcutaneous injectable growth hormone for children with growth hormone...

Three JAK Inhibitors Get Boxed Warnings, Modified Indications

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer,...

NCCN Recommends Third COVID-19 Dose for Patients With Cancer

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Experts at the National Comprehensive Cancer Network (NCCN) have now issued...

Scientists Say Biden Jumped the Gun With Vaccine Booster Plan

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The Biden administration’s plans to make covid-19 booster shots available next...

Only a Fraction of Breakthrough Infections as Cases Surge

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Meggan Ingram was fully vaccinated when she tested positive for COVID-19...

Guidance on Additional COVID-19 Vaccine Dose for MS Patients

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Patients age 12 years and older with multiple sclerosis (MS) who...

FDA Warns Again About Robotic Mastectomy, Breaks New Ground

The US Food and Drug Administration (FDA) today issued a new safety communication about the use of robotically assisted mastectomy, warning patients and physicians that...

FDA Warns Providers to Stop Using Eco-Med Products

The US Food and Drug Administration (FDA) is urging healthcare providers to immediately stop use of and discard all Eco-Med ultrasound gels and lotions because...

FDA Approves Pfizer’s Tick-borne Encephalitis Vaccine

The US Food and Drug Administration (FDA) has approved Pfizer’s TicoVac vaccine for the treatment of tick-borne encephalitis (TBE). The vaccine is approved outside of...

FDA OKs Belzutifan for Cancers Tied to von Hippel-Lindau Disease

The US Food and Drug Administration (FDA) approved belzutifan (Welireg) for adult patients with von Hippel-Lindau disease (VHL) who require therapy for associated renal cell...

Covid vaccine: U.S. FDA authorizes COVID-19 vaccine boosters for the immunocompromised

The U.S. Food and Drug Administration on Thursday authorized a booster dose of COVID-19 vaccines from Pfizer Inc and Moderna Inc for people with compromised...

CDC Reports Burkholderia cepacia and B pseudomallei Outbreaks

The CDC and FDA have announced an outbreak of at least 15 Burkholderia cepacia infections associated with contaminated ultrasound gel used to guide invasive procedures...

FDA May OK COVID Booster for Vulnerable Adults Before Weekend: Media

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) could green-light a booster...

Potential Military Vaccine Mandate Brings Distrust, Support

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. SAN DIEGO (AP) — Since President Joe Biden asked the Pentagon...

FDA Clears New Enzyme Replacement Therapy for Pompe Disease

The US Food and Drug Administration (FDA) has approved a new enzyme replacement therapy, avalglucosidase alfa (Nexviazyme, Genzyme), for patients aged 1 year and older...

Class I Recall of Boston Scientific INGENIO Family of Pacemakers

Boston Scientific has recalled the INGENIO family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because the devices may incorrectly transition to safety mode. Safety...

The FDA Knew the Heart Pumps Could Be Unsafe, Yet They Were Used

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular...

FDA Rejects Tenapanor for Control of Phosphorus in Kidney Disease

The US Food and Drug Administration (FDA) is asking for an additional clinical trial to demonstrate greater benefits of tenapanor before it can decide on...

FDA Approves Anifrolumab (Saphnelo) as New Lupus Treatment

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic...

New Investigational Helmet Device Shrinks Glioblastoma

A case report describes a novel helmet device that generates a noninvasive oscillating magnetic field and that shrunk a glioblastoma tumor by about a third....