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| 1 | Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome |
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| 2 | Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations | FDA |
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| 3 | FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines | FDA |
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| 4 | FDA In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines | FDA |
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| 5 | Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic | FDA |
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| 6 | Fulcrum Therapeutics Announces U.S. Food and Drug Administration Grants Fast Track Designation to Losmapimod for the Potential Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD) |
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| 7 | Eagle Hill Expands Healthcare Footprint with Business Transformation Services for US Food and Drug Administration |
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| 8 | The FDA issues Report Regarding its Oversight Activities |
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| 9 | FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer |
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| 10 | FDA Approves Treatment for Chronic Kidney Disease |
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| 11 | FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov | FDA |
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| 12 | FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose | FDA |
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| 13 | Pierre vaccine site ready for children after FDA approval |
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| 14 | FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers |
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| 15 | FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker | FDA |
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| 16 | FDA Must Establish Limits for All Animal Antibiotics |
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| 17 | Heron Therapeutics Announces US FDA Approval of ZYNRELEF™ (HTX-011) for the Management of Postoperative Pain for up to 72 Hours |
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| 18 | FDA In Brief: FDA Releases Investigation Report Following 2020 Salmonella Outbreak Linked to Red Onions |
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| 19 | Quercis Announces Special Protocol Assessment Agreement with US Food and Drug Administration |
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| 20 | Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | FDA |
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| 21 | PharmaEssentia Resubmits Application to the U.S. FDA For Ropeginterferon alfa-2b-njft to Treat Polycythemia Vera (PV) |
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| 22 | FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 | FDA |
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| 23 | FDA expected to OK Pfizer vaccine for teens within week |
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| 24 | Coronavirus (COVID-19) Update: May 11, 2021 | FDA |
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| 25 | U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma |
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| 26 | Neurolutions Receives US Food and Drug Administration De |
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| 27 | FDA outlines plan for making inspections more consistent going forward |
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| 28 | Nkarta Receives NKX019 IND Clearance from US Food and Drug Administration for Treatment of Relapsed/Refractory B Cell Malignancies |
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| 29 | FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients |
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| 30 | FDA calls for input on peptide evaluation |
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| 31 | Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency |
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| 32 | Church & Dwight Initiates Voluntary Recall of Select Vitamins Due to Isolated Manufacturing Issue |
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| 33 | FDA investigation of 2020 Salmonella outbreak linked to red onions points to irrigation water – Produce Blue Book |
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| 34 | FDA grants orphan drug designation for Endogena's lead program targeting retinitis pigmentosa |
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| 35 | FDA Seeks Public Comments on PMI Application to Market IQOS 3 as Modified Risk Tobacco Product |
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| 36 | FDA Warns Cell Phone, Smart Watch Magnets Affect Medical Devices |
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| 37 | Are COVID Vaccines FDA Approved? Here's How the Process Works |
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| 38 | FDA approves J&J Vision's therapeutic contact lenses for myopia |
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| 39 | Advocates Cheer FDA Review of Abortion Pill Restrictions |
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| 40 | Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 |
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| 41 | Coronavirus (COVID-19) Update: May 4, 2021 | FDA |
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| 42 | 7 May 2021 Coronavirus (COVID-19) Update: May 7, 2021 | FDA |
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| 43 | What difference would full FDA approval make for COVID-19 vaccines? |
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| 44 | Pfizer aims for full FDA approval of vaccine |
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| 45 | FDA to start sampling lettuce grown in Salinas Valley, CA – Produce Blue Book |
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| 46 | Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-605, the First TurboCAR™ Candidate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma |
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| 47 | Stop Using This Supplement Immediately, FDA Warns |
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| 48 | Transplanted Pancreatic Islets: Are They Drugs or Organs? |
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| 49 | New trial data for Keytruda in triple-negative breast cancer |
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| 50 | FDA guidance: M9 biopharmaceutics classification system-based biowaive |
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| 51 | FDA grants fast-track designation to Cerecor's Covid-19 treatment |
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| 52 | Velvet Ice Cream Recalls Various Products Due to Possible Listeria Risk |
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| 53 | TÜV SÜD North America Gains U.S. FDA (Food & Drug Administration) ASCA Accreditation for Medical Device Testing |
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| 54 | Coronavirus (COVID-19) Update: April 16, 2021 | FDA |
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| 55 | FDA grants EUA to Qiagen's digital SARS-CoV-2 antibody test |
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| 56 | Coronavirus (COVID-19) Update: April 27, 2021 | FDA |
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| 57 | Hand sanitizer recall: FDA says Medically Minded brand found to contain methanol |
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| 58 | Hershey Voluntarily Recalls Hershey's Chocolate Shell Topping Due to Undeclared Almonds |
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| 59 | FDA Puts Investigational FSHD Therapy Losmapimod on Fast Track |
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| 60 | New FDA Program Could Help Standardize Regulatory Submissions |
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| 61 | BridgeBio Pharma Receives FDA Fast Track Designation for Investigational Gene Therapy for ... |
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| 62 | Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand Organic Black Beans, and O Organic Brand Black Beans and O Organic Brand Chili Beans Due to Compromised Hermetic Seal |
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| 63 | Palisade Bio Receives FDA Fast Track Designation for LB1148 |
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| 64 | Novavax begins vaccinating children in trial at University of Maryland School of Medicine |
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| 65 | City of St. Louis Teenagers Become Eligible For COVID-19 Vaccines |
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| 66 | Sara Lee Frozen Bakery Issues Allergy Alert on Undeclared Peanuts in Pecan Pies |
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| 67 | Cannabis firms ready FDA ingredient notifications with eye on legalization |
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| 68 | Coronavirus (COVID-19) Update: April 20, 2021 |
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| 69 | Global Sanitizers Issues Voluntary Nationwide Recall of Medically Minded Hand Sanitizer Due to Presence of Undeclared Methanol |
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| 70 | Johnson & Johnson Vision Announces FDA Approval of ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management |
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| 71 | Jule's Foods Issues Voluntary Recall of Jule's Foods Products Because of Possible Health Risk |
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| 72 | Hanmi's lung fibrosis drug candidate wins FDA orphan drug status |
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| 73 | Biogen's experimental eye treatment fails to meet study goal |
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| 74 | ZOLL Medical Receives FDA IDE Approval for Initiation of ISO SHOCK (Incorporating Supersaturated Oxygen in Shock) Feasibility Study |
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| 75 | First Genetically Modified Mosquitoes Released in U.S. Are Hatching Now |
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| 76 | Dash Xclusive Issues Voluntary Nationwide Recall of Imperia Elita Vitaccino Coffee Due to the Presence of Undeclared Sibutramine and Fluoxetine |
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| 77 | Ex-FDA Chief Sees 'Struggle' To Vaccinate More Than Half U.S. Population |
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| 78 | Metro Nashville Public Schools partners with Vanderbilt to get kids ages 12-15 vaccinated |
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| 79 | Vaccinations for youth 12 and above expand on Maui |
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| 80 | Faron sub-licenses US rights to traumakine patent |
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| 81 | QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies |
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| 82 | SCYNEXIS Secures Term Loan Facility for up to $60 Million |
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| 83 | Emergent Bio Execs to Testify Before Congress Following Vaccine Manufacturing Mistake |
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| 84 | Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde |
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| 85 | argenx Reports First Quarter 2021 Financial Results and Provides Business Update |
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| 86 | Applied DNA Provides Clarification on Newly Authorized Asymptomatic Serial Screening Indication for LineaTM COVID-19 Assay Kit and Press Release Published 12 May 2021 |
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| 87 | Palatin Hosting Key Opinion Leader Webinar in Role of Melanocortin Agonists in Inflammation and the Treatment of Ocular Indications |
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| 88 | Praxis Precision Medicines Prices Public Offering of Common Stock |
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| 89 | FDA Grants EUA to Applied DNA LineaTM COVID-19 Assay Kit for Asymptomatic Screening of Individuals with Serial Testing |
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| 90 | J&J COVID-19 vaccine manufacturing halted at U.S. plant that had contamination issue |
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| 91 | Long Beach will start vaccinating kids ages 12+ starting Thursday |
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| 92 | Antengene Announces IND Approval in China for a Global Phase III Trial of Selinexor in Advanced or Recurrent Endometrial Cancer |
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| 93 | Hemp in Onslow, Part One: Intro to Hemp and CBD, a potential medicine for veterans |
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| 94 | CBD tablet significantly improves diabetic peripheral neuropathic pain |
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| 95 | Guan's Mushroom Co Recalls Enoki Because of Possible Health Risk |
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| 96 | Desktop Health Receives FDA Clearance for Flexcera for Next Generation 3D Printed Dentures |
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| 97 | Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | FDA |
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| 98 | FDA Approves First Treatment for COVID-19 FDA approved Veklury |
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| 99 | FDA Takes Actions to Help Lower US Prescription Drug Prices | FDA |
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| 100 | FDA, Mexican Counterparts Enhance Food Safety Partnership | FDA |
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