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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
GlaxoSmithKline Slips as FDA Approves Asthma Drug for Adults, Not Younger Patients
May 1, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amgen’s T-Vec Cancer Therapy Gets FDA Panel OK
April 30, 2015
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Kythera Grabs FDA Approval for Chin Fat-Busting Drug
April 30, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Analysts Cheer As Amgen Nabs Long-Awaited FDA Approval of Heart Failure Drug Corlanor
April 16, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Gilead’s Next-Gen HIV Drug Heads to the FDA, Stock Soars
April 8, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Clovis Oncology Shares Leap as FDA Deems Ovarian Cancer Drug a Breakthrough, Company Preps for ARIEL3
April 7, 2015
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2 min read
FDA
Berry Genomics NextSeq CN500 Instrument And Non-Invasive Prenatal Testing Reagent Kit Receives Chinese FDA Premarket Clearance
March 31, 2015
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Panel Backs GlaxoSmithKline, Theravance’s Breo for Adults, Not Kids
March 20, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
100 Pfizer Scientists and Their Journey to Bring Ibrance to Market
March 9, 2015
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Novartis AG’s Sandoz Bags Approval for First Biosimilar to be Sold in the U.S.
March 6, 2015
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3 min read
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PRESS RELEASES
FDA
Medtronic Expands Leadership in Treating Bladder and Bowel Control Conditions with Two New FDA-Approved Products: InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads
August 3, 2020
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5 min read
FDA
Lannett Announces Launch Of FDA Approved Levothyroxine Tablets
August 3, 2020
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2 min read
FDA
Xencor Earns Milestone Payment from MorphoSys for FDA Approval of Monjuvi® (tafasitamab-cxix) in the United States
July 31, 2020
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5 min read
FDA
Tuberous Sclerosis Alliance Lauds FDA Approval of Epidiolex® to Treat Seizures in People with Tuberous Sclerosis Complex
July 31, 2020
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2 min read
FDA
FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
July 31, 2020
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4 min read
FDA
FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
July 31, 2020
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16 min read
FDA
FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
July 31, 2020
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16 min read
Drug Development
Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19
July 31, 2020
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7 min read
FDA
FDA Approves EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms
July 31, 2020
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5 min read
FDA
FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma
July 30, 2020
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27 min read
FDA
U.S. Food and Drug Administration Approves STELARA® (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
July 30, 2020
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13 min read
FDA
U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology
July 30, 2020
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5 min read
FDA
Endologix Announces First Commercial Implant of ALTO Abdominal Stent Graft System & Official Start of U.S. Commercial Release
July 30, 2020
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6 min read
FDA
Marinus Pharmaceuticals Receives Rare Pediatric Disease Designation from FDA for Ganaxolone for the Treatment of CDKL5 Deficiency Disorder (CDD)
July 30, 2020
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7 min read
FDA
Regulus Therapeutics Announces FDA Orphan Drug Designation of RGLS4326 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
July 29, 2020
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5 min read
FDA
Truvian Sciences Receives FDA Emergency Use Authorization for Easy Check COVID-19 IgM/IgG™ Test
July 29, 2020
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3 min read
Drug Development
INOVIO Receives Orphan Drug Designation From U.S. FDA for DNA Medicine INO-3107 To Treat Rare Disease Recurrent Respiratory Papillomatosis (RRP)
July 29, 2020
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9 min read
FDA
FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19: Currently in development by NeuroRx and Relief Therapeutics under Fast Track Designation
July 29, 2020
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5 min read
FDA
Neocis Announces New FDA 510(k) Clearance Enabling the Yomi® Dental Robotic System to Assist with Full Arch Implant Treatment
July 28, 2020
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3 min read
FDA
Black Diamond Therapeutics Granted Fast Track Designation by the FDA for BDTX-189 for the Treatment of Adult Patients with a Solid Tumor Harboring an Allosteric HER2 Mutation or an EGFR or HER2 Exon 20 Insertion Mutation
July 28, 2020
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6 min read
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