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MyChesCo

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  • COVID-19

Medical Regulatory Issues

Aclaris Therapeutics
Products and Services / Research

Aclaris Therapeutics Announces Preliminary Topline Data from Trial of Oral ATI-450

January 20, 2021January 20, 2021 - by MyChesCo

WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, announced positive preliminary topline results from a 12-week, Phase …

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Dog
National

FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy

January 18, 2021January 18, 2021 - by MyChesCo

WASHINGTON, D.C. — The U.S. Food and Drug Administration has granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to control seizures in dogs …

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Artificial Intelligence
Government / National / Technology

FDA Releases Artificial Intelligence/Machine Learning Action Plan

January 15, 2021January 13, 2021 - by MyChesCo

WASHINGTON, D.C. — The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a …

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US Food and Drug Administration (FDA)
Health / Medical / National

FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

December 31, 2020December 30, 2020 - by MyChesCo

WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of …

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Verrica Pharmaceuticals Inc
Products and Services / Research

Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102

December 25, 2020December 25, 2020 - by MyChesCo

WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug …

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Klisyri (tirbanibulin)
Products and Services / Research

Almirall Announces FDA Approval of Klisyri® (tirbanibulin), a New Innovative Topical Treatment for Actinic Keratosis

December 21, 2020December 19, 2020 - by MyChesCo

EXTON, PA — Almirall, S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced that Klisyri® (tirbanibulin) has been approved by the U.S. Food and Drug Administration (FDA) for the topical …

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Zynerba Pharmaceuticals
Products and Services

Zynerba Pharmaceuticals Provides Regulatory Update on Zygel™ in Fragile X Syndrome

December 18, 2020December 18, 2020 - by MyChesCo

DEVON, PA — Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, has provided an update on its meeting with …

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covid-19 test
Health / Medical / National

FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

December 18, 2020December 17, 2020 - by MyChesCo

WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 …

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Klisyri (tirbanibulin)
Products and Services / Research

FDA Grants Approval for Actinic Keratosis Treatment

December 16, 2020December 16, 2020 - by MyChesCo

EXTON, PA — Almirall, S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced that Klisyri® (tirbanibulin) has been approved by the U.S. Food and Drug Administration (FDA) …

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Food and Drug Administration
National

FDA Authorizes First COVID-19 and Flu Combination Test for Use With Home-Collected Samples

December 8, 2020December 6, 2020 - by MyChesCo

WASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and …

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Most Read

  • COVID-19 Vaccine Phase 1A Additions and Vaccine Supply in Chester County
  • OCR Publishes Proposed Rule Protecting Infants Born Alive from Discrimination on the Basis of Disability
  • 2021 Tax Filing Season Begins Feb. 12; IRS Outlines Steps to Speed Refunds During Pandemic
  • U.S. Department of Labor Issues Three Wage and Hour Opinion Letters
  • IRS Free File Available Now; Claim Recovery Rebate Credit and Other Tax Credits
  • Bill Gates-Funded Solar Dimming Project Risks the Lives of Millions and Must be Stopped

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Chester County Events

  • National Irish Coffee Day at The Watermark at Bellingham Drive-By
    • 01/21/2021
  • A Real-Life Scavenger Hunt for Grown-Ups On King Street,Malvern!
    • 01/21/2021
      Malvern
  • Cancer (Oncology) Massage
    • 01/26/2021
      Exton
  • Intro to Practical Defensive Pistol (Indoor)
    • 01/27/2021
      Elverson
  • Machinery Rescue Awareness and Operations
    • 01/30/2021
      West Chester
  • all events

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Recent Articles

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