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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Boehringer Ingelheim Corporation Wins FDA Approval For Lung Disease Drug Ofev
October 15, 2014
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Gilead’s New Hepatitis C Drug Harvoni
October 10, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Celgene’s Psoriasis Drug Wins Approval For New Indication
September 24, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Eli Lilly and Company Gets Thumbs Up From FDA For Diabetes Drug Trulicity
September 18, 2014
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1 min read
FDA
Auxilium Pharmaceuticals, VIVUS, Inc.'s Faster-Acting Erectile Dysfunction Drug Wins FDA Approval
September 18, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Baxter International, Inc., Halozyme Therapeutics, Inc.'s HYQVIA
September 15, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Panel Recommends Approval Of NPS Pharmaceuticals, Inc.'s Natpara To Treat Hypoparathyroidism
September 12, 2014
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Orexigen’s Long-Awaited Weight Loss Drug Contrave
September 11, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Keryx Biopharmaceuticals’ Kidney Drug Ferric Citrate With Warnings, Shares Crash
September 8, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Merck & Co.'s New-Kind Of Cancer Drug Keytruda
September 4, 2014
 · 
2 min read
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PRESS RELEASES
FDA
Aerus Product Announcements
July 2, 2020
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6 min read
FDA
EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
July 2, 2020
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5 min read
FDA
Axonics® Receives FDA Approval for 3T Full-Body MRI Scans
July 1, 2020
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3 min read
FDA
Venus Concept Inc. Announces FDA 510(k) Clearance for Venus Viva MDVenus Viva MD is a new skin rejuvenation solution with differentiated features
July 1, 2020
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6 min read
FDA
Kroger Health Receives FDA Emergency Use Authorization for its COVID-19 Test Home Collection Kit
July 1, 2020
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5 min read
FDA
Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities
July 1, 2020
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8 min read
Drug Development
Anti-viral and Anti-Inflammatory Response: GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 Phase 2 Trial in USA
July 1, 2020
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4 min read
FDA
FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
June 30, 2020
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25 min read
FDA
Ultragenyx Announces U.S. FDA Approval of Dojolvi™ (UX007/triheptanoin), the First FDA-Approved Therapy for the Treatment of Long-chain Fatty Acid Oxidation Disorders
June 30, 2020
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8 min read
FDA
IlluminOss Medical Receives FDA Clearance for Expanded Clinical Use for Pelvic, Clavicle and Small-Bone Fractures
June 30, 2020
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2 min read
FDA
Oncternal Therapeutics Announces Orphan Drug Designations of Cirmtuzumab ROR1 Antibody for Treatment of Mantle Cell Lymphoma and for Treatment of Chronic Lymphocytic Leukemia
June 30, 2020
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9 min read
FDA
Ancora Heart Receives IDE Approval for CorCinch-HF Pivotal Study of the AccuCinch® Ventricular Restoration System
June 30, 2020
 · 
5 min read
FDA
CoreLink Announces FDA Clearance of F3D-C2 Stand-alone Cervical Spine System
June 30, 2020
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2 min read
FDA
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
June 29, 2020
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37 min read
FDA
FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
June 29, 2020
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4 min read
FDA
FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional
June 29, 2020
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3 min read
FDA
Halozyme Announces Roche Receives FDA Approval For Phesgo™ (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme’s ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer
June 29, 2020
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7 min read
FDA
FDA Approves Genentech’s Phesgo (Fixed-dose Combination of Perjeta and Herceptin for Subcutaneous Injection) for HER2-positive Breast Cancer
June 29, 2020
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12 min read
FDA
Beckman Coulter’s SARS-CoV-2 IgG Antibody Test Receives FDA Emergency Use Authorization
June 29, 2020
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7 min read
FDA
Chiasma Announces FDA Approval of MYCAPSSA® (Octreotide) Capsules, the First and Only Oral Somatostatin Analog
June 26, 2020
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11 min read
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