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FDA

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
FDA Grants Breakthrough Therapy Status To Takeda Pharmaceutical Co. Ltd.'s Ixazomib
December 5, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Speedy FDA Approval For Amgen’s Leukemia Immunotherapy BLINCYTO
December 4, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
National Institute for Clinical Excellence (NICE) Reverses October Decision And Approves Roche’s Oncology Drug Gazyvaro
December 2, 2014
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
Drug Development
FDA Requires Additional Data On Bristol-Myers Squibb Company’ Hep C Daclatasvir
November 26, 2014
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1 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
France Strikes Deal For Gilead Sciences, Inc.'s Hep C Drug Sovaldi
November 21, 2014
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Purdue Pharma L.P. Wins FDA Approval For Powerful Painkiller Hysingla
November 20, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Regeneron, ReGen Therapeutics Plc Eczema Drug Dupilumab Gets FDA Breakthrough Therapy Designation
November 20, 2014
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2 min read
Mylan Inc., Theravance, Inc. Partner Up for $265 Million COPD Pact
FDA
Regeneron’s Eylea Gets Japanese Nod For Macular Edema
November 18, 2014
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Genzyme Corporation’s Lemtrada For MS
November 17, 2014
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2 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Eli Lilly Wins FDA Approval For Gastric Cancer Combination Drug
November 6, 2014
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2 min read
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PRESS RELEASES
Press Releases
Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
February 17, 2026
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1 min read
Press Releases
OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma
February 17, 2026
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1 min read
Press Releases
Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy
February 17, 2026
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10 min read
Press Releases
FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
February 17, 2026
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32 min read
Press Releases
FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)
February 17, 2026
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13 min read
Press Releases
Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average
February 17, 2026
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4 min read
Press Releases
Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL
February 17, 2026
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6 min read
Press Releases
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma
February 17, 2026
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6 min read
Press Releases
Cytokinetics Announces European Commission Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
February 17, 2026
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9 min read
Press Releases
Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study
February 17, 2026
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2 min read
Press Releases
NRx Pharmaceuticals (Nasdaq:NRXP) Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting
February 17, 2026
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5 min read
Press Releases
Cyclerion Therapeutics Announces Progress Toward CYC-126 Phase 2 Proof-of-Concept Study with FDA Feedback and Formation of Clinical Advisory Board
February 17, 2026
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12 min read
Press Releases
Kane Biotech Announces FDA 510(k) Clearance for revyve® Antimicrobial Skin and Wound Cleanser
February 17, 2026
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4 min read
Press Releases
LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System
February 16, 2026
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2 min read
Press Releases
CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial
February 16, 2026
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4 min read
Press Releases
Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP
February 15, 2026
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7 min read
Press Releases
MEDIPOST Inc. Submits IND Amendment With U.S. Food and Drug Administration to Initiate Phase III Trial
February 13, 2026
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1 min read
Press Releases
Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery
February 13, 2026
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4 min read
Press Releases
InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device
February 13, 2026
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2 min read
Press Releases
HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer
February 13, 2026
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5 min read
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