FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
Action FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in pediatric patients aged four...
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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Dec 16, 20212 min read
FDA approves first drug to decrease urine protein in IgA nephropathy, a rare kidney disease
Action FDA has granted accelerated approval for Tarpeyo (budesonide) delayed release capsules to reduce proteinuria (increased protein...
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Provision Consulting Group
Dec 15, 20213 min read
FDA Approves First Drug to Prevent Graft Versus Host Disease
Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host...
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Provision Consulting Group
Dec 9, 20214 min read
FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds
Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds Today, the U.S....
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Provision Consulting Group
Dec 9, 20214 min read
FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19
Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain...
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Provision Consulting Group
Dec 6, 20213 min read
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric...
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Provision Consulting Group
Nov 29, 20212 min read
FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions
The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying...
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Provision Consulting Group
Nov 24, 20212 min read
FDA Approves First Treatment for Post- Transplant Infection that is Resistant to Other Drugs
The U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12...
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Provision Consulting Group
Nov 22, 20212 min read
FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism
The U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older...
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Provision Consulting Group
Nov 19, 20214 min read
FDA Expands Eligibility for COVID-19 Vaccine Boosters
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech...
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Provision Consulting Group
Nov 5, 20212 min read
FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and...
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Provision Consulting Group
Nov 2, 20217 min read
FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
Immediately and thoroughly rinse eyes with gently running water if this occurs What safety concern is FDA announcing? The U.S. Food and...
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Provision Consulting Group
Oct 29, 20215 min read
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years
Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of...
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Provision Consulting Group
Oct 27, 20212 min read
FDA Continues Efforts to Detect and Assess Asbestos in Cosmetics for Consumers
The following quote is attributed to Linda Katz, director of the FDA's Office of Cosmetics and Colors: “The FDA remains dedicated to...
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Provision Consulting Group
Oct 21, 20215 min read
FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
The U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The...
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Provision Consulting Group
Oct 19, 20213 min read
FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology
Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid...
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Provision Consulting Group
Oct 13, 20211 min read
FDA approves add-on drug for adults with rare form of blood vessel inflammation
Action FDA has approved Tavneos (avacopan) as an add-on treatment to standard therapy including glucocorticoids for adult patients with...
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Provision Consulting Group
Oct 5, 20212 min read
FDA authorizes new over-the-counter home COVID-19 test
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home...
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Provision Consulting Group
Sep 28, 20212 min read
FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol
FDA has approved Repatha (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapies for...
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Provision Consulting Group
Sep 24, 20217 min read
FDA updates on sunscreen requirements
FDA regulates sunscreens, which are nonprescription drugs, to help make sure that consumers have access to safe and effective sun...
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