Food And Drug Administration

Fda Relents On Mix And Match For Third Dose

Here is the NYT account, they sound both confused and confusing.  How about “if you have had J&J, it is fine and probably preferable to get a further dose of Moderna or Pfizer”?  Yet suddenly it is fine. And it is the usual story...
Related topics: Pfizer

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J&j, Moderna Covid-19 Booster Jabs Near Fda Authorization

Johnson & Johnson JNJ announced that the FDA’s Vaccines and Related Biological Products advisory committee (VRBPAC) unanimously voted in favor of emergency use authorization (EUA) to the booster dose of its single-shot COVID-19 vaccine for...
Related topics: Vaccines

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Roche's (rhhby) Tecentriq Gets Fda Nod For Another Indication

Roche RHHBY recently announced that the FDA has approved immuno-oncology drug Tecentriq (atezolizumab) for another indication.Tecentriq is now approved as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage...
Related topics: Cancer, Oncology, Chemotherapy

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The Price Tag Of Fda's 'onco-exceptionalism'

(MedPage Today) -- More people than ever were on new cancer drugs backed by relatively weak evidence, and the money spent on these pricey drugs exceeded that of dollars spent on those with a known overall survival (OS) benefit, according to...
Related topics: Cancer, Oncology

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Fda To Make Isotretinoin Prescribing Gender Neutral

(MedPage Today) -- In a nod toward transgender inclusiveness, the FDA revised the iPLEDGE risk-modification program for isotretinoin by rewording the reproductive categories for patients. Beginning December 13, patients prescribed isotretinoin...

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First Interchangeable Humira Biosimilar Approved

(MedPage Today) -- The FDA approved Cyltezo as the first interchangeable biosimilar to adalimumab (Humira), with indications ranging from rheumatoid arthritis (RA) to inflammatory bowel disease, Boehringer Ingelheim announced late on Friday. Of...
Related topics: Rheumatoid Arthritis, Arthritis

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Dr. Gottlieb Warns New "super Variant" Is Behind Latest Covid Comeback In Uk

Dr. Gottlieb Warns New "Super Variant" Is Behind Latest COVID Comeback In UK The UK thought it had COVID mostly licked, but Dr. Scott Gottlieb (former head of the US FDA) warned Monday that a new "super-strain" evolved from the delta...

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Shock: Fda Delays Moderna Vax For Adolescents Citing Concern Of Myocarditis Risk In Children

Sweden and Denmark announced last week they were halting Moderna COVID vaccinations for those under 30-years-old due to possible side effects. This was very big news. The two nations saw ample evidence to ban the vaccine for its youth. Pfizer filed...
Related topics: Vaccines, Pfizer

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Fauci Said Fda Panel's Recommendation Shows J&j Vaccine 'should Have Been A Two-dose Vaccine To...

Dr. Anthony Fauci appears on ABC News' "This Week" on Sunday, October 17. ABC News/This Week Dr. Anthony Fauci said the Johnson & Johnson COVID-19 vaccine likely "should have been a two-dose vaccine to begin with." An FDA...
Related topics: Vaccines

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Ghrelin Aids Weight Loss; Fda Says Cut Salt; More Bariatric Surgeries With Medicaid

(MedPage Today) -- Higher levels of fasting ghrelin helped induce abdominal visceral fat loss and improved insulin sensitivity in people who followed the green-Mediterranean diet. "The findings suggest fasting ghrelin levels may serve as a...
Related topics: Medicaid, Insulin, Diet

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Fda, Cdc Considering Whether To Allow Mixing Covid Booster Shots

U.S. regulators are considering revising the rules for COVID vaccines to allow people to opt for a booster shot from a different maker.
Related topics: Centers For Disease Control And Prevention, Vaccines

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Blood Pressure And Fluid Retention Drugs Recalled Over Cancer Concerns

The FDA has published a new recall advisory from Lupin Pharmaceuticals over two different drugs: Hydrochlorothiazide and Irbesartan. The company, which stopped marketing these particular drugs in January, says it is recalling the batches due to...
Related topics: Blood Pressure, Cancer, Oncology, Marketing

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The Fda Could Authorize The First Covid-19 Pill In December - Here's Who May Be Eligible

Pills seen with the Merck logo in the background. Jakub Porzycki/NurPhoto/Getty Images The FDA will meet to discuss Merck's COVID-19 pill in late November, which means the treatment could get authorized in December. The drug seems to prevent...
Related topics: Merck & Co

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J&j Boosters Are On The Horizon For Everyone Who Got That Shot - Regardless Of Age, Job, Or Health

Unlike Pfizer and Moderna's booster shot applications, which the FDA authorized only for certain groups, J&J's extra dose will be available to anyone who received the first shot once it's authorized. Brendan McDermid/Reuters An FDA...
Related topics: Pfizer, Reuters

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First Adjuvant Immunotherapy Ok'd In Non-small Cell Lung Cancer

(MedPage Today) -- The FDA approved the PD-L1 inhibitor atezolizumab (Tecentriq) as adjuvant treatment following surgery and platinum-based chemotherapy for stage II-IIIa non-small cell lung cancer (NSCLC) that expresses PD-L1. The new approval...
Related topics: Lung Cancer, Cancer, Oncology, Chemotherapy

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Independent Fda Panel Votes To Authorize Booster Shots For Johnson & Johnson Vaccine

An independent Food and Drug Administration advisory panel on Friday voted to move forward with Johnson & Johnson vaccine boosters.
Related topics: Vaccines

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Fda Backs Boosters, Travel Restrictions Lift, And More News

Catch up on the most important updates from this week.

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Perkinelmer (pki) Receives Eua From Fda For Latest Assay

PerkinElmer, Inc. PKI recently announced that it has received Emergency Use Authorization (EUA) from the FDA for the PKamp Respiratory SARS-CoV-2-RT-PCR Panel 1 assay. Following this announcement, qualified laboratories can commence using this...

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Moderna Slides After Fda Delays Youth Vaccine Decision Due To Heart Inflammation Issues

Moderna Slides After FDA Delays Youth Vaccine Decision Due To Heart Inflammation Issues Following the same 'science' as the four Nordic nations that either banned completely or selectively, the FDA has decided to delay a decision on...
Related topics: Vaccines

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The Most Common Side Effects To Expect After Your Moderna Booster: Headache, Fatigue, And Pain At...

A Palestinian medic displays a vial of the Moderna COVID-19 vaccine. AP Photo/Oded Balilty, File An expert FDA panel recommended to OK Moderna's booster shot for certain high-risk groups. The vaccine-maker is applying to use a half-strength...
Related topics: Vaccines, Health Photos

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