Verrica Pharmaceuticals Reports Fourth Quarter and Full-Year 2020 Financial Results
WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) recently announced financial results for the fourth quarter ended December 31, 2020.
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West Chester-based Biotech Company Receives FDA Approval for Investigational New Drug
WEST CHESTER, PA — Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, announced the approval of an Investigational New Drug (IND) …
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FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy
WASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized the marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy …
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FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
WASHINGTON, D.C. — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) this week for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals …
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FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
WASHINGTON, D.C. — The U.S. Food and Drug Administration recently announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional …
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FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation
WASHINGTON, D.C. — The U.S. Food and Drug Administration granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed …
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Teleflex Announces Submission of Biologics License Application
WAYNE, PA — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced it has submitted a Biologics License Application (BLA) to …
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Education Department Amplifies USDA Expansion of SNAP Benefits
WASHINGTON, D.C. — The U.S. Department of Education—in collaboration with the U.S. Department of Agriculture (USDA)—has issued guidance to postsecondary institutions to inform them about temporarily expanded Supplemental Nutrition Assistance Program …
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FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
WASHINGTON, D.C. — The U.S. Food and Drug Administration this week issued guidance for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential …
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FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and …
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