FDA NEWS: French National Charged With Making False Statements To FDA To Fraudulently Obtain Control Of Pharmaceutical Product
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FDA NEWS: French National Charged With Making False Statements To FDA To Fraudulently Obtain Control Of Pharmaceutical Product

Department of Justice U.S. Attorney’s Office District of New Jersey FOR IMMEDIATE RELEASE Wednesday, November 24, 2021 NEWARK, N.J. – A French national will make his initial appearance today for his role in an attempt to fraudulently gain control of the rights to sell a weight-loss drug in the United States, Acting U.S. Attorney Rachael…

FDA NEWS: Nine Indicted In Counterfeit Promethazine-Codeine Drug Trafficking Conspiracy
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FDA NEWS: Nine Indicted In Counterfeit Promethazine-Codeine Drug Trafficking Conspiracy

Department of Justice U.S. Attorney’s Office Eastern District of Texas FOR IMMEDIATE RELEASE Friday, November 12, 2021 BEAUMONT, Texas – A federal grand jury in Beaumont has returned a three-count indictment charging nine individuals in drug trafficking conspiracy in the Eastern District of Texas, announced Acting U.S. Attorney Nicholas J. Ganjei today. The indictment was…

HEALTH: FDA Pharmacists Help You Use Medicines Safely
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HEALTH: FDA Pharmacists Help You Use Medicines Safely

Image Español How often has this happened to you: You pick up a prescription at the pharmacy and later realize you have questions about something in the directions or warnings. Or you buy an over-the-counter (OTC) drug but aren’t sure about the correct dosage after reading the label. That’s where pharmacists come in. Whether at…

HEALTH: Mercury Poisoning Linked To Skin Products
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HEALTH: Mercury Poisoning Linked To Skin Products

Español Tagalog 日本語 简体中文  한국어  Việt Whatever your complexion, it’s important to use products that will help your skin and not damage it. But as you wade through the beauty aisles, the U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions that contain mercury. How will…

FDA NEWS: FDA Approves New Imaging Drug To Help  Identify Ovarian Cancer Lesions
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FDA NEWS: FDA Approves New Imaging Drug To Help Identify Ovarian Cancer Lesions

For Immediate Release: November 29, 2021 The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery. Cytalux is indicated for use…

FDA NEWS: FDA Approves First Treatment For Common Type Of Post-Transplant Infection That Is Resistant To Other Drugs
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FDA NEWS: FDA Approves First Treatment For Common Type Of Post-Transplant Infection That Is Resistant To Other Drugs

For Immediate Release: November 23, 2021 Today, the U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance)…

BUSINESS: Seelos Therapeutics Announces The Acquisition Of An Exclusive License To IX Biopharma’s Proprietary Wafer Based Delivery Platform For Sublingual Ketamine
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BUSINESS: Seelos Therapeutics Announces The Acquisition Of An Exclusive License To IX Biopharma’s Proprietary Wafer Based Delivery Platform For Sublingual Ketamine

NEW YORK, Nov. 24, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from…

FOOD SAFETY: Additional time is granted to identify and vet expert witnesses in the Blue Bell trial
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FOOD SAFETY: Additional time is granted to identify and vet expert witnesses in the Blue Bell trial

. The judge who will be preside at the criminal trial of Paul Kruse, former president of Blue Bell Ice Cream, is giving the defense team extra time to find the expert witnesses they might need. Federal Judge Robert Pitman extended the deadline for the defense to share their expert witness list with the government…

HEALTH NEWS: Democrats plan to expand Medicare hearing benefits. What can consumers expect?
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HEALTH NEWS: Democrats plan to expand Medicare hearing benefits. What can consumers expect?

HEALTH NEWS: The new plan will cover certain hearing aids for individuals with “moderately severe, severe or profound hearing loss.” It also allows seniors who are enrolled in traditional Medicare to receive a hearing aid every five years. (DigitalVision / Getty Images) President Joe Biden’s massive domestic spending bill would add hearing benefit to the…

BUSINESS: POLARITYTE DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That A Class Action Lawsuit Has Been Filed Against PolarityTE, Inc., And Encourages Them To Contact The Firm
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BUSINESS: POLARITYTE DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That A Class Action Lawsuit Has Been Filed Against PolarityTE, Inc., And Encourages Them To Contact The Firm

November 22, 2021 23:00 ET | Source: Bragar Eagel & Squire NEW YORK, Nov. 22, 2021 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against PolarityTE, Inc. (“PolarityTE” or the “Company”) (NASDAQ: PTE) in the United States District…

RECALL: The Spice House Issues Allergy Alert On Undeclared Sesame In Sichuan Chili BBQ Rub
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RECALL: The Spice House Issues Allergy Alert On Undeclared Sesame In Sichuan Chili BBQ Rub

Summary Company Announcement Date: November 22, 2021 FDA Publish Date: November 22, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared sesame Company Name: The Spice House Brand Name: Product Description: Company Announcement The Spice House is voluntarily recalling Sichuan Chili BBQ Rub because it may contain undeclared sesame. People who…

RECALL: Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall Of Levetiracetam Injection, USP Due To Lack Of Sterility Assurance
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RECALL: Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall Of Levetiracetam Injection, USP Due To Lack Of Sterility Assurance

Summary Company Announcement Date: November 19, 2021 FDA Publish Date: November 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Sagent Pharmaceuticals, Inc. Brand Name: Product Description: Company Announcement CHICAGO, IL – November 19, 2021 – Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of four…

FRONT PAGES: A Wearable Device Can Detect Opioid Overdose And Reverse It
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FRONT PAGES: A Wearable Device Can Detect Opioid Overdose And Reverse It

Newswise — A research team at the University of Washington has developed a wearable device to detect and reverse an opioid overdose. The device, worn on the stomach like an insulin pump, senses when a person stops breathing and moving, and injects naloxone, a lifesaving antidote that can restore respiration. The results demonstrate the proof-of-concept of…

HEALTH: Mayo Clinic Rolls Out COVID-19 Booster Vaccinations For All Adults
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HEALTH: Mayo Clinic Rolls Out COVID-19 Booster Vaccinations For All Adults

The Advisory Committee on Immunization Practices approved Moderna and Pfizer COVID-19 booster vaccinations for adults ― meaning anyone 18 and older ― at its meeting Friday, Nov. 19. This is in addition to groups previously approved for boosters, such as health care workers and those age 65 and older. Mayo Clinic will roll out COVID-19…

BUSINESS: 23andMe Announces Redemption All Outstanding Warrants
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BUSINESS: 23andMe Announces Redemption All Outstanding Warrants

November 22, 2021 16:15 ET | Source: 23andMe Holding Co. SUNNYVALE, Calif., Nov. 22, 2021 (GLOBE NEWSWIRE) — 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading consumer genetics and research company, today announced that it will redeem all of its outstanding warrants (the “Public Warrants”) to purchase shares of Class A common stock of 23andMe…

BUSINESS: Teacher Guard launches, offering natural supplements that support teachers throughout the US
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BUSINESS: Teacher Guard launches, offering natural supplements that support teachers throughout the US

*)Couple-Owned Company develops all-natural health supplements for teachers while donating 10% with every purchase for classroom essentials. TeacherGuard is a brand new line of health supplements that are based in Florida. Michelle and Randy Getchis Jr., husband-and-wife entrepreneurs, created their supplements with the goal of improving the health of teachers using all-natural ingredients. Classroom Formula…

BUSINESS: Obseva Announces U.S. FDA Acceptance Of New Drug Application For Linzagolix
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BUSINESS: Obseva Announces U.S. FDA Acceptance Of New Drug Application For Linzagolix

FDA Accepts NDA for Linzagolix for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange GENEVA, Switzerland November 22, 2021 – Obseva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today…

BUSINESS: Vifor Pharma To Acquire Sanifit To Further Strengthen Late-Stage Pipeline In Nephrology
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BUSINESS: Vifor Pharma To Acquire Sanifit To Further Strengthen Late-Stage Pipeline In Nephrology

November 22, 2021 01:05 ET | Source: Laboratoris Sanifit S.L. Press Release Vifor Pharma to acquire Sanifit to further strengthen late-stage pipeline in nephrology Vifor Pharma to acquire Sanifit, a clinical-stage cardio-renal biopharmaceutical company focused on treatments for progressive vascular calcification disorders, complementing and strengthening the Group’s growing nephrology portfolioSanifit’s lead compound, SNF472 is a novel,…

FDA NEWS: FDA In Brief: FDA Announces Investigation Of E. Coli O157:H7 Outbreak Linked To Spinach
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FDA NEWS: FDA In Brief: FDA Announces Investigation Of E. Coli O157:H7 Outbreak Linked To Spinach

For Immediate Release: November 16, 2021 The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: “The FDA, along with the CDC and our state and local partners, is working to investigate a multistate outbreak of E. coli O157:H7 Outbreak associated with spinach consumption. Thus far, the FDA has…

FDA NEWS: Coronavirus (COVID-19), Update: November 16, 2021
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FDA NEWS: Coronavirus (COVID-19), Update: November 16, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological…

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