Tag: fda
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...
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...
FDA Fully Approves Pfizer COVID Vaccine, Paves Way for Mandates
The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.
“While millions of people...
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...
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...
COVID Skeptics Request Blood Transfusions From Unvaccinated Donors
Tuesday, August 17, 2021 (Kaiser News) — The nation’s roiling tensions over vaccination against covid-19 have spilled into an unexpected arena: lifesaving blood transfusions....
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...
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 Wants To Fully Approve Pfizer Vaccine By Early September: Report
The U.S. Food and Drug Administration is aiming to grant full approval to Pfizer-BioNTech’s COVID-19 vaccine by early next month, according to a New York...
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...
FDA’s Fast-Track Approval Exposed as Lax, in Need of Reform
Since the US Food and Drug Administration (FDA) established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track...
Pfizer Vaccine Protection Wanes After 6 Months: Study
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Pfizer’s COVID-19 vaccine continues to show strong protection against serious illness...
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