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Approvals

FDA
New Peanut Test Kits Approved For Food Industry
October 19, 2005
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1 min read
FDA
Monsanto Gets Final China OK For 5 Biotech Imports
October 19, 2005
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1 min read
FDA
FDA Sees Rebound In Approval Of Innovative Drugs In 2003
October 19, 2005
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1 min read
Drug Development
FDA OKs Ecstasy Study In Cancer Patients
October 19, 2005
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1 min read
FDA
Abbott Labs Gets Clearance On Safety Of Test-Kit Plant
October 19, 2005
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1 min read
FDA
FDA Approves Weight-Loss Pill for Teens
October 19, 2005
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1 min read
FDA
Panel Approves The Pill/Folic Acid Combo
October 19, 2005
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1 min read
FDA
Cancer Gene Therapy Is First To Be Approved
October 19, 2005
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1 min read
FDA
WHO Approves Use Of New Combination AIDS Pills
October 19, 2005
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1 min read
FDA
Controversial Primate Experiment Lab Approved
October 19, 2005
 · 
1 min read
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PRESS RELEASES
FDA
Clyraguard Shows Complete Inactivation of SARS-CoV-2 Virus in Study at Galveston National Lab
May 19, 2020
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3 min read
Drug Development
Covis Pharma B.V. Initiates Phase 3 Clinical Trial of Alvesco (Ciclesonide) Inhaler for the Treatment of COVID-19
May 19, 2020
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5 min read
FDA
FDA Approves Two Emergency INDs to Administer Organicell Flow for COVID-19
May 19, 2020
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4 min read
FDA
Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States
May 19, 2020
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2 min read
FDA
FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
May 18, 2020
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11 min read
FDA
Zebra Medical Vision Secures its 5th FDA Clearance, Making Its Vertebral Compression Fractures AI Solution Available in the U.S.
May 18, 2020
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3 min read
FDA
NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients
May 18, 2020
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5 min read
Drug Development
FDA Clears the Investigational New Drug Application to Enable the Phase II Trial of ViralClear’s Merimepodib, Oral Solution to Treat Adult Patients with Advanced COVID-19, to Proceed
May 18, 2020
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6 min read
FDA
Agilent PD-L1 Assay Receives FDA Approval for Use as a Companion Diagnostic
May 18, 2020
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2 min read
FDA
FDA Grants Full Approval of Deciphera Pharmaceuticals’ QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
May 15, 2020
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13 min read
FDA
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%
May 15, 2020
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34 min read
FDA
FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors
May 15, 2020
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4 min read
FDA
Rubraca® Approved in the U.S. as Monotherapy Treatment for Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Been Treated with Androgen Receptor-Directed Therapy and a Taxane-Based Chemotherapy
May 15, 2020
 · 
12 min read
FDA
Leading BioSciences Receives IND Clearance for Phase 2 COVID-19 StudyLB1148 Now Available for Investigational Use to Treat Pulmonary Dysfunction Associated with COVID-19 Pneumonia
May 15, 2020
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5 min read
FDA
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Pomalyst® (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma
May 15, 2020
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20 min read
FDA
Q BioMed Launches New Website Strontium89.com and Digital Marketing Campaign for Strontium89 (Strontium Chloride Sr-89 Injection, USP) Non-opioid Treatment for Metastatic Bone Pain
May 15, 2020
 · 
7 min read
FDA
Hologic Granted FDA Emergency Use Authorization for Its Second Molecular Test for COVID-19
May 15, 2020
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4 min read
FDA
Seelos Therapeutics Receives Rare Pediatric Disease Designation for SLS-005 (Trehalose) in Sanfilippo Syndrome
May 15, 2020
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1 min read
Drug Development
FDA approves COVID-19 trial after successful emergency use of umbilical stem cells from RESTEM
May 14, 2020
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6 min read
FDA
FDA Clears AgenTus IND for Allogeneic iNKT Cell Therapy
May 13, 2020
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4 min read
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