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Approvals

Policy
Biopharma Update on the Novel Coronavirus: October 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.
October 6, 2020
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4 min read
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BioSpace Editorial Staff
FDA
LabCorp Receives EUA from FDA for New High-Speed COVID-19 Test
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.
October 2, 2020
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3 min read
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Brandon May
FDA
Judge Sides with FDA, Jacobus Pharma in Fight Over LEMS Treatment Approval
Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
September 30, 2020
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2 min read
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Alex Keown
FDA
FDA Gives GSK’s Nucala the Greenlight for Hypereosinophilic Syndrome
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
September 28, 2020
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2 min read
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Brandon May
JHVEPhoto/GettyImages
FDA
FDA Grants Mereo’s Setrusumab Rare Pediatric Disease Designation
Under that designation, Mereo may qualify for a voucher that can be used for a priority review of a subsequent marketing application for a different product than Setrusumab.
September 24, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: October 2
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 2, 2020.
September 22, 2020
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2 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 30, 2020.
September 22, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 28, 2020.
September 22, 2020
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2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 25
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.
September 22, 2020
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4 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.
September 22, 2020
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5 min read
 · 
BioSpace Editorial Staff
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PRESS RELEASES
FDA
United Therapeutics Announces FDA Approval of Tyvaso DPI™
May 24, 2022
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11 min read
FDA
FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years
May 24, 2022
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11 min read
FDA
MannKind’s Technosphere® Inhalation Platform Utilized in FDA-Approved Tyvaso DPI™
May 24, 2022
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9 min read
FDA
Xcovery SHP2 Inhibitor IND Approved by US FDA
May 23, 2022
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2 min read
FDA
Altamira Therapeutics Receives Philippines’ FDA Approval of Bentrio Nasal Spray
May 23, 2022
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5 min read
FDA
AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson’s Disease
May 20, 2022
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9 min read
FDA
FDA Approves Dupixent® (dupilumab) as First Treatment for Adults and Children Aged 12 and Older with Eosinophilic Esophagitis
May 20, 2022
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24 min read
FDA
Press Release: FDA approves Dupixent® (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis
May 20, 2022
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18 min read
FDA
FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder
May 20, 2022
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4 min read
FDA
TherapeuticsMD Receives U.S. Food and Drug Administration (FDA) Approval for Supplemental New Drug Application (sNDA) for ANNOVERA®
May 20, 2022
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5 min read
FDA
Anika Receives FDA 510(k) Clearance for the X-Twist™ Knotless Fixation System, Expanding its Sports Medicine Soft Tissue PortfolioX-Twist
May 20, 2022
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5 min read
FDA
GlobalData Plc: FDA Approved 122 New Drug Applications and Biologics License Applications in 2021
May 19, 2022
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6 min read
FDA
Adiso Therapeutics’ ADS024 Selected for Oral Presentation at 2022 Digestive Disease Week Annual Meeting
May 19, 2022
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4 min read
FDA
SIGA Receives Approval from the FDA for Intravenous (IV) Formulation of TPOXX® (tecovirimat)- FDA approval provides an important option for those unable to take oral formulation of TPOXX -
May 19, 2022
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6 min read
Drug Development
Indaptus Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Decoy20 in Solid Tumors
May 19, 2022
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6 min read
FDA
Mersana Therapeutics Announces FDA Grant of Orphan Drug Designation to XMT-2056 for the Treatment of Gastric Cancer
May 19, 2022
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5 min read
Drug Development
Cardiol Therapeutics Announces FDA Investigational New Drug Application (IND) Authorization for Multicenter Phase II Open-Label Pilot Study of CardiolRx(TM) for Recurrent Pericarditis
May 17, 2022
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10 min read
FDA
Nephros Receives FDA 510(k) Clearance for HDF Assist Module
May 17, 2022
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3 min read
FDA
Linear Health Sciences Announces U.S. FDA Clearance and Health Canada Approval of Its Orchid Safety Release Valve (SRV)
May 17, 2022
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3 min read
FDA
FDA approves Lilly’s Mounjaro™ (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes
May 13, 2022
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16 min read
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