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Ridgewood NJ, the U.S. Food and Drug Administration (FDA) has raised serious concerns about the safety of Tom’s of Maine toothpaste after identifying bacteria contamination and unsanitary conditions at the company’s Sanford, Maine, manufacturing plant.
Continue reading FDA Flags Bacteria and Contamination Issues at Tom’s of Maine Toothpaste Factory
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Ridgewood NJ, in a groundbreaking development, the U.S. Food and Drug Administration (FDA) has approved the first-ever nasal spray to treat potentially severe allergic reactions. The new spray, marketed under the brand name Neffy, offers a needle-free alternative to traditional injectable epinephrine products like the EpiPen, which has been in use since 1987.
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Ridgewood NJ, in a significant development, outside advisers to the U.S. Food and Drug Administration (FDA) unanimously endorsed the efficacy of Eli Lilly’s experimental Alzheimer’s drug, donanemab, for patients with early Alzheimer’s disease. This vote precedes the FDA’s impending decision on the drug’s approval. The panel’s discussion highlighted some unique aspects of Lilly’s trial, which differed notably from the trial design of Eisai and Biogen’s Leqembi, another Alzheimer’s drug that recently gained U.S. approval following a similar advisory committee review.
Continue reading FDA Panel Endorses Eli Lilly’s Experimental Alzheimer’s Drug Donanemab
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North Brunswick NJ, BioAegis Therapeutics, Inc., a clinical-stage company developing therapies for inflammatory diseases through a portfolio built around plasma gelsolin, a highly conserved and abundant endogenous human immune regulatory protein, announces that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for recombinant plasma gelsolin to proceed for the treatment of acute respiratory distress syndrome (ARDS).
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Penns Grove NJ, The U.S. Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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Trenton NJ, a New York man today admitted perpetrating a scheme to defraud more than 70 investors through a long-running securities offering fraud that raised more than $4 million and caused investor losses of more than $3.5 million, Acting U.S. Attorney Rachael A. Honig announced.
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Ridgewood NJ, Aducanumab is the first new treatment for Alzheimer’s disease that has been approved for use in the US in nearly 20 years. It targets the underlying cause of the disease rather than its symptoms. While it is not a miracle drug, its approval will be a huge boost to dementia research. Alzheimer’s disease affects more than 30 million people around the world, most over the age of 65.
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New Brunswick NJ, Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following authorization.
Clinical Contributors to this Story Juan C. Ravell, M.D. Hackensack Meridian Health
Hackensack NJ, The Pfizer-BioNTech and Moderna COVID-19 vaccines were given Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in mid-December 2020. Prior to authorization by the FDA, these vaccines underwent the same rigorous safety and effectiveness standards as all other vaccines. Quickly, vaccine distribution began, starting with health care professionals on the frontlines of patient care.
Continue reading What Ingredients are Really in the COVID Vaccines
Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
the staff of the Ridgewood blog
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Ridgewood NJ, Governor Phil Murphy today announced the acquisition of 15 point-of-care ID NOW testing instruments from the federal government to expand access to COVID-19 testing in New Jersey. The portable, rapid testing machines will be dispersed to health care systems throughout the state, will be able to test for COVID-19 and process specimens in approximately 5-13 minutes.
US has conducted more COVID 19 tests in 8 days than South Korea did in 8 weeks.
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Ridgewood NJ, Following Gov. Phil Murphy’s weekend executive order that mandated people stay home and shuttered all non-essential businesses, Assemblyman Kevin J. Rooney announced he was issuing a resolution to urge the U.S. Food and Drug Administration (FDA) to ramp up testing for COVID-19 so that people could return to work.
