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| 1 | Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants |
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| 2 | COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging |
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| 3 | FDA.gov Coronavirus (COVID-19) Update: February 23, 2021 |
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| 4 | FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy |
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| 5 | US Drug Regulator Removes Key Requirement for Future COVID Vaccine Approvals |
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| 6 | Johnson & Johnson's one-shot COVID-19 vaccine effective and safe- FDA staff |
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| 7 | Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 |
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| 8 | Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate |
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| 9 | FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders |
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| 10 | FDA Provides the Latest COVID Updates |
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| 11 | FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older |
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| 12 | FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma |
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| 13 | Puzzle Medical Devices Inc. Receives US Food and Drug Administration (FDA) Breakthrough Device Designation for Its Revolutionary Minimally Invasive Transcatheter Heart Pump |
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| 14 | Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into US, Protect US Consumers |
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| 15 | Chinook Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for CHK-336 for Treatment of Primary Hyperoxaluria |
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| 16 | FDA grants clearance for Rhythmlink's Sticky Pad Surface Electrodes |
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| 17 | Heart Valve Collaboratory Announces U.S. Food and Drug Administration Participation in Collaborative Community |
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| 18 | FDA Names First Acting Director Of Medical Device Cybersecurity |
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| 19 | Johnson & Johnson's one-shot COVID-19 vaccine effective, safe: FDA staff |
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| 20 | ViiV Healthcare Submits Supplemental New Drug Application to US FDA for Expanded Use of Cabenuva (cabotegravir, rilpivirine) as an HIV Treatment for Use Every 2-Months |
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| 21 | FDA.gov Coronavirus (COVID-19) Update: February 5, 2021 |
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| 22 | FDA says J&J 1-dose shot prevents COVID; final decision soon |
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| 23 | U.S. FDA Accepts for Priority Review Pfizer's... | INN |
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| 24 | Intrommune Receives IND Clearance From US Food and Drug Administration for INT301 |
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| 25 | Tebentafusp Named FDA Breakthrough Therapy for Advanced Eye Cancer |
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| 26 | Locate Bio's Chondro3 Granted FDA Breakthrough Device Designation |
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| 27 | Coronavirus (COVID-19) Update: January 26, 2021 |
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| 28 | Jacobs Institute hires Carlos Pena, formerly of US Food and Drug Administration's Office of Neurological and Physical Medicine Devices |
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| 29 | Biofrontera submits study report of pharmacokinetics study to FDA |
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| 30 | Janssen's Single-Dose COVID-19 Vaccine Under FDA Review |
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| 31 | Dascena Announces FDA Breakthrough Device Designation Granted to Machine Learning Diagnostic Method |
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| 32 | Kura Oncology Receives FDA Breakthrough Therapy Designation for Tipifarnib in Head and Neck Squamous Cell Carcinoma |
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| 33 | Newsfeed Now: FDA finds Johnson & Johnson’s COVID-19 vaccine effective and safe; veterinarians say six-legged puppy ‘a miracle’ |
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| 34 | FDA, in Initial Review of NurOwn for ALS, Finds Data Lacking |
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| 35 | Can AI help to improve seafood safety? |
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| 36 | 2021 Biopharma Update on the Novel Coronavirus: February 23 |
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| 37 | NDAL MFG INC Issues Voluntary Nationwide Recall of ManukaGuard Allercleanse Nasal Spray Due to Contamination with Yeast |
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| 38 | El Abuelito Recalls Queso Fresco Products Because of Possible Health Risk |
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| 39 | Johnson & Johnson requests emergency authorization from FDA for Covid vaccine |
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| 40 | Data confirms single-dose Covid-19 vaccine is safe: Live updates |
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| 41 | Dow Jones Today, Stocks Sag Ahead Of Powell, Day 2; J&J Jumps On FDA Vaccine Comments |
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| 42 | Ellodi Pharmaceuticals Announces Fast Track Designation Granted by the FDA to APT-1011 for the Treatment of Eosinophilic Esophagitis (EoE) |
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| 43 | Import alerts include problems with cheese, shrimp, misbranding, pesticides |
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| 44 | 2020 at FDA: A Year of Unparalleled Contributions to Public Health |
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| 45 | FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine |
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| 46 | FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting |
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| 47 | FDA, Mexican Counterparts Enhance Food Safety Partnership |
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| 48 | FDA Warns Companies Illegally Selling CBD Products | FDA |
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| 49 | FDA Approves First Treatment for COVID-19 |
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| 50 | FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV |
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| 51 | Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators |
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| 52 | FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients |
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| 53 | FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs |
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| 54 | FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs |
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| 55 | FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order |
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| 56 | CBP, FDA Seize Counterfeit, Unauthorized E-Cigarettes |
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| 57 | FDA Approves First Drug to Treat Rare Metabolic Disorder |
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| 58 | FDA Releases New Outbreak Investigation Table |
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| 59 | FDA Takes Actions to Help Lower US Prescription Drug Prices |
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| 60 | FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses |
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| 61 | FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications |
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| 62 | FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff |
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| 63 | FDA Requiring Labeling Changes for Benzodiazepines |
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| 64 | FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety |
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| 65 | FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings |
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| 66 | FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia |
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| 67 | FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products |
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| 68 | FDA Launches the Digital Health Center of Excellence |
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| 69 | FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs |
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| 70 | Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system |
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| 71 | FDA Releases Artificial Intelligence/Machine Learning Action Plan |
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| 72 | Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System |
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| 73 | US Food and Drug Administration approves Pfizer Covid-19 vaccine |
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| 74 | FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations |
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| 75 | FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer |
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| 76 | USDA, FDA Strengthen US Food Supply Chain Protections |
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| 77 | FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels |
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| 78 | COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card |
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| 79 | FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases |
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| 80 | FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer |
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| 81 | FDA Warns Companies Illegally Selling Hangover Remedies |
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| 82 | FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord |
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| 83 | FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance |
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| 84 | FDA Approves First Treatment for Ebola Virus |
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| 85 | Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate |
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| 86 | FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging |
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| 87 | Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test |
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| 88 | FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories |
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| 89 | FDA Warns Website Operators Illegally Selling Opioids to Consumers |
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| 90 | FDA Approves Oral Treatment for Spinal Muscular Atrophy |
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| 91 | Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools |
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| 92 | FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults |
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| 93 | Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines |
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| 94 | FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD |
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| 95 | Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem |
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| 96 | FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention |
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| 97 | FDA Warns Dietary Supplement Companies Illegally Selling Products Containing Cesium Chloride |
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| 98 | COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers |
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| 99 | FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies |
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| 100 | Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 |
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