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Approvals

FDA
FDA Clears Test to Help Doctors Manage Heart Transplant Patients
August 27, 2008
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1 min read
FDA
FDA On Pace To Approve 18 New Drugs In 2008
August 8, 2008
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1 min read
FDA
FDA Approves 2008-2009 Season’s Flu Vaccines: CSL Limited, Afluria. GlaxoSmithKline Biologicals, Fluarix. ID Biomedical Corporation of Quebec, FluLaval. MedImmune Vaccines, FluMist. Novartis Vaccines & Diagnostics, Inc., Fluvirin. Sanofi Pasteur, Fluzone.
August 6, 2008
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1 min read
FDA
CDRH Updates:: Invitrogen Corporation SPOT-Light(R) HER2 CISH(TM) Kit - P050040 Approval
August 1, 2008
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1 min read
FDA
FDA (JOBS) Panel: No Black Box Warning On Epilepsy Drugs
July 11, 2008
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1 min read
FDA
Drugmakers Agree to Wait on Advertising New Drugs; Congressional Hearing Focused on Pfizer Inc.'s Lipitor, Johnson & Johnson’s Procrit, and Vytorin Sold by Merck & Co., Inc. and Schering-Plough Pharmaceuticals
June 18, 2008
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1 min read
FDA
Simcere Pharmaceutical Group Given SFDA Approval for Generic Antibiotic
May 14, 2008
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1 min read
FDA
China Biologic Products Reports Two SFDA Successes
May 1, 2008
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1 min read
FDA
Overview of FDA Meeting on Embryonic Stem Cells
April 28, 2008
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1 min read
FDA
Pharmaceutical Safety: If A Drug Has FDA’s OK, Should You Be Able To Sue? -- Editorial, Opinion Piece
April 28, 2008
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1 min read
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PRESS RELEASES
FDA
FDA Approves New Dupixent® (dupilumab) Pre-filled Pen Designed to Support More Convenient Self-Administration
June 19, 2020
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18 min read
FDA
Roche receives FDA approval for cobas EZH2 Mutation Test as a companion diagnostic for patients with follicular lymphoma
June 19, 2020
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4 min read
FDA
Ovid Therapeutics Receives FDA Rare Pediatric Disease Designation for OV101 for the Treatment of Angelman Syndrome
June 19, 2020
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7 min read
FDA
FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening
June 18, 2020
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3 min read
FDA
Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for Relapsed/Refractory Follicular Lymphoma
June 18, 2020
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14 min read
FDA
Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita® (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO)
June 18, 2020
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11 min read
FDA
Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients
June 18, 2020
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3 min read
FDA
TFF Pharmaceuticals Receives Orphan Drug Designation for Tacrolimus Inhalation Powder
June 18, 2020
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5 min read
FDA
Almirall Announces FDA Approval Of Updated Label For Seysara® (Sarecycline) Tablets
June 18, 2020
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7 min read
FDA
USGI Medical Receives FDA Approval to Expand US Pilot Study Evaluating Incisionless Weight Loss Procedure – POSE 2.0
June 18, 2020
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4 min read
FDA
Dicerna Receives Rare Pediatric Disease Designation From U.S. Food and Drug Administration for Nedosiran for Treatment of Primary Hyperoxaluria
June 18, 2020
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8 min read
FDA
Enexor Ventilators Granted FDA Emergency Use Authorization
June 17, 2020
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2 min read
FDA
FoundationOne®CDx Receives FDA Approval as the First Companion Diagnostic to Identify Advanced Cancer Patients with Solid Tumors that are Tumor Mutational Burden-High and Appropriate for Immunotherapy Treatment with KEYTRUDA® (pembrolizumab)
June 17, 2020
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6 min read
FDA
FDA Approves Second Biomarker-Based Indication for Merck’s KEYTRUDA® (pembrolizumab), Regardless of Tumor Type
June 17, 2020
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36 min read
FDA
FDA Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease
June 16, 2020
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2 min read
Business
FDA and Health Canada Approve Thermedical’s Degassed Saline to Help Reduce Risk of StrokeMontreal Heart Institute First to use New Degassed Saline During Innovative Cardiac Ablation Procedure
June 16, 2020
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4 min read
FDA
FDA and Health Canada Approve Thermedical’s Degassed Saline to Help Reduce Risk of Stroke
June 16, 2020
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4 min read
FDA
SpectronRx Announces High-Capacity, 1.5 Hour HymonTMSARS-CoV-2 Test Kit for Detection of Novel Coronavirus (COVID-19)
June 16, 2020
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2 min read
FDA
FDA approves Lyumjev™ (insulin lispro-aabc injection), Lilly’s new rapid-acting insulin
June 15, 2020
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14 min read
FDA
Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer
June 15, 2020
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12 min read
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