6224 Articles Matching "fda"
Aurobindo obtains FDA OK for 2 generics
Dec 03, 2022 Generic Sinemet is used to treat Parkinson’s disease; generic Valcyte is used for the prevention of Cytomegalovirus disease in kidney and heart transplant patients at high...
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FDA Moves to Ease Restrictions on Gay Men Giving Blood
Dec 02, 2022Currently, FDA policy does not allow blood donation from men who have had sex with other men in the past three...
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FDA pulls Covid antibody treatment because it's not effective against dominant omicron variants
Dec 02, 2022The FDA said bebtelovimab is no longer authorized for use because it is not expected to neutralize the omicron BQ.1 and BQ.1.1...
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FDA considering shift toward individual risk-based assessments for blood donors
Dec 01, 2022The US Food and Drug Administration is considering shifting its blood donation policy away from blanket assessments toward questionnaires that focus more on individual risk, it said...
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The N Protein, A New Target For Anti-Covid Drugs
Nov 30, 2022FDA-approved drug inhibits SARS-CoV-2 nucleocapsid phosphorylation and viral...
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FDA Warning: Raw Oysters Contaminated With Sapovirus May Be In 13 States
Nov 28, 2022Dai One Food Company, Ltd., has issued a recall of all potentially affected frozen half shell...
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Claims That RSV Surge Due To Covid-19 Vaccines Take Clinical Trial Data Out Of Context
Nov 27, 2022Here are what passages from the U.S. Food and Drug Administration (FDA) documents say about RSV and the Moderna and Pfizer-BioNTech Covid-19 mRNA...
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FDA warns against consuming certain raw oysters distributed to 13 states after reported illnesses
Nov 25, 2022The Food and Drug Administration is advising people in 13 states not to eat certain raw oysters from South Korea after at least one person in Las Vegas got sick with a virus that can cause diarrhea and...
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FDA approves $3.5 million treatment for hemophilia, now the most expensive drug in the world
Nov 24, 2022The US Food and Drug Administration on Tuesday approved Hemgenix, a new drug to treat hemophilia. Manufacturer CSL Behring set the price at $3.5 million per treatment, making it the most expensive drug in the...
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Eugia Pharma Specialities gets FDA OK for generic AmBisome Liposome for Injection
Nov 24, 2022 Amphotericin B liposome for injection, 50 mg /vial is a partnership product from TTY...
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AEYE Health receives FDA 510(k) for AI-backed diabetic retinopathy screening
Nov 22, 2022The Israeli startup said it's now focused on receiving clearance to use its AEYE-DS system with a portable...
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FDA: Amoxicillin Shortage Hits U.S., How This Antibiotic Is Misused For Respiratory Illnesses
Nov 20, 2022Amoxicillin is an antibiotic commonly used to frequently used to treat bacterial infection of the ears, nose, throat, respiratory tract, urinary tract, or...
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New Lawsuit Aims To Revoke FDA Approval Of Abortion Drug
Nov 19, 2022Medication abortion has become increasingly important to abortion access in the wake of the Supreme Court overturning Roe v....
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Using an Online Pharmacy to Buy Meds? It's Buyer Beware, FDA Says
Nov 19, 2022The FDA warns that while some pharmacy websites operate legally and can offer convenience, privacy and lower costs, others may be selling unapproved, counterfeit and unsafe...
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As STDs Proliferate, Companies Rush to Market At-Home Test Kits. But Are They Reliable?
Nov 19, 2022The popularity of at-home covid tests has amplified calls from public health researchers and diagnostic companies to make home testing similarly routine for sexually transmitted diseases. But FDA guidelines are...
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Lab-grown meat is OK for consumption, FDA says
Nov 18, 2022The US Food and Drug Administration has given a safety clearance to lab-grown meat for the first time....
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FDA identifies Insulet Omnipod DASH battery recall as Class I
Nov 18, 2022The Class I recall of the DASH system comes days after the company issued a voluntary urgent medical device "correction" for its Omnipod 5...
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Lab-grown meat is OK for human consumption, FDA says
Nov 18, 2022Upside Foods, a California-based company that makes meat from cultured chicken cells, will be able to begin selling its products once it has been inspected by the US Department of...
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FDA approves first treatment to delay onset of type 1 diabetes
Nov 18, 2022A biologic therapy that delays the onset of type 1 diabetes received approval from the US Food and Drug Administration on...
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FDA lays out plan to combat bacterial contamination of baby formula
Nov 17, 2022The US Food and Drug Administration is charting a plan to enhance its surveillance of infant formula for Cronobacter...
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