FDA proposal would allow more men who have sex with men to donate blood
The US Food and Drug Administration is proposing a blood donation policy that focuses on individual risk instead of blanket assessments, the agency said Friday -- opening donation to more gay and bisexual men. (Source: CNN.com - Health)
Source: CNN.com - Health - January 28, 2023 Category: Consumer Health News Source Type: news

FDA pulls authorization for AstraZeneca ’s Covid antibody drug Evusheld
The Food and Drug Administration has withdrawn emergency use authorization for AstraZeneca’s Covid-19 antibody cocktail Evusheld as the treatment is not expected to neutralize the currently dominant XBB.1.5 subvariant of omicron. The FDA had limited Evusheld’s use earlier this month for the same…#astrazeneca #evusheld #fda #omicron #elililly (Source: Reuters: Health)
Source: Reuters: Health - January 28, 2023 Category: Consumer Health News Source Type: news

Annual? Bivalent? For all? Future of COVID shots murky after FDA deliberations
The US Food and Drug Administration's committee of independent vaccine experts gathered Thursday to discuss the future of COVID-19 shots. The meeting seemed primed for explosive debate. Earlier in the week, the FDA released documents that made clear the agency is holding steadfast to its idea that…#fda #pauloffit #vaccines #wuhan #archanachatterjee #cdc #xbb #jerryweir #ba45 #xbb1 (Source: Reuters: Health)
Source: Reuters: Health - January 28, 2023 Category: Consumer Health News Source Type: news

FDA Says No to Regulating CBD Products as Supplements
FRIDAY, Jan. 27, 2023 -- The U.S. Food and Drug Administration said Thursday it cannot regulate cannabidiol (CBD) supplements because there is not enough evidence on their safety. The agency also called on Congress to create new rules for what has... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 27, 2023 Category: Pharmaceuticals Source Type: news

Updated Booster Shots, Not Original COVID-19 Vaccines, Should Be Standard: FDA Panel
FRIDAY, Jan. 27, 2023 -- The U.S. Food and Drug Administration vaccine advisory panel on Thursday voted unanimously to recommend that the agency phase out original versions of COVID-19 vaccines for use in the unvaccinated, in favor of updated... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 27, 2023 Category: Pharmaceuticals Source Type: news

FDA proposes individual risk assessments for blood donors, opening up opportunities for more men who have sex with men to donate
The US Food and Drug Administration is proposing to move to a blood donation policy that focuses on individual risk instead of relying on blanket assessments, the agency said Friday. (Source: CNN.com - Health)
Source: CNN.com - Health - January 27, 2023 Category: Consumer Health News Source Type: news

New Blood Donation Rules to Loosen Restrictions on Gay and Bisexual Men
The F.D.A. proposed a more individualized policy based on questions about sexual behavior and risks. (Source: NYT Health)
Source: NYT Health - January 27, 2023 Category: Consumer Health News Authors: Christina Jewett and Emily Anthes Tags: Homosexuality and Bisexuality Blood Donation Discrimination Acquired Immune Deficiency Syndrome Shortages Tests (Medical) Food and Drug Administration United States Source Type: news

FDA pulls authorization for COVID antibody treatment over lack of effectiveness
Evusheld, the preventative monoclonal antibody treatment for COVID-19, has lost its emergency use authorization in the U.S. as it is most likely not effective against the strains of the coronavirus currently circulating. The announcement from the Food and Drug Administration (FDA) comes weeks…#evusheld #fda #astrazeneca #molnupiravir (Source: Reuters: Health)
Source: Reuters: Health - January 27, 2023 Category: Consumer Health News Source Type: news

FDA Moves to Ease Rules for Blood Donations from Gay Men
WASHINGTON — The U.S. is moving to further ease restrictions on blood donations from gay and bisexual men and other groups that typically face higher risks of HIV. The Food and Drug Administration on Friday announced draft guidelines that would do away with the current three-month abstinence requirement for donations from men who have sex with men. Instead, all potential donors would be screened with a new questionnaire that evaluates their individual risks for HIV based on sexual behavior, recent partners, and other factors. If finalized, many gay and bisexual men in monogamous relationships would be able to donate ...
Source: TIME: Health - January 27, 2023 Category: Consumer Health News Authors: Matthew Perrone/AP Tags: Uncategorized healthscienceclimate Public Health wire Source Type: news

FDA proposes easing blood donation restrictions based on sexuality
The U.S. Food and Drug Administration Friday proposed loosening restrictions based on gender and sexual orientation for blood donors in the United States. (Source: Health News - UPI.com)
Source: Health News - UPI.com - January 27, 2023 Category: Consumer Health News Source Type: news

What new questions will I be asked when I donate blood?
The Food and Drug Administration drafted guidelines for blood donations that do away with some long-standing disqualifications for gay and bisexual men. (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - January 27, 2023 Category: Consumer Health News Authors: Teddy Amenabar Source Type: news

Criminal action against drug counterfeiters: assessment of the FDA Office of Criminal Investigation database 2016 through 2021 - White CM.
The objective of this study was to describe law enforcement oversight of counterfeit drugs by the Food and Drug Administration (FDA) in the United States from 2016 through 2021.METHODSThe FDA Office of Criminal Investigation database with ... (Source: SafetyLit)
Source: SafetyLit - January 27, 2023 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

Evusheld Loses U.S. Authorization Since It ’ s Not Effective Against New Variants
AstraZeneca Plc’s COVID antibody drug is no longer authorized for use in the U.S., regulators said Thursday, as it’s unlikely to work against strains of the virus that are now dominant across the country. Astra’s drug, called Evusheld, was authorized in December 2021 to prevent COVID infection in high-risk people, but has been rendered less effective by the virus’ mutations. At this point, fewer than 10% of the variants currently circulating in the U.S. appear to be responsive to Astra’s treatment, the U.S. Food and Drug Administration said in a statement. In the meantime, Astra said in a stat...
Source: TIME: Health - January 27, 2023 Category: Consumer Health News Authors: Madison Muller/Bloomberg Tags: Uncategorized bloomberg wire COVID-19 healthscienceclimate Source Type: news

Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI ® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma
RARITAN, New Jersey, January 27, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) for the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma met its primary endpoint of significant improvement in progression-free survival (PFS) at the first pre-specified interim analysis. As a result of meeting the primary endpoint, the Independent Data Monitoring Commi...
Source: Johnson and Johnson - January 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

FDA ends emergency use authorization for COVID-19 drug Evusheld
The Food and Drug Administration on Thursday withdrew emergency use authorization for the COVID-19 drug Evusheld because of its lack of effectiveness against some of the more widespread coronavirus variants. (Source: Health News - UPI.com)
Source: Health News - UPI.com - January 27, 2023 Category: Consumer Health News Source Type: news