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FDA

FDA
FDA Approves Rockwell Medicall’s Triferic™ For Iron Replacement And Maintenance Of Hemoglobin In Hemodialysis Patient
January 26, 2015
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5 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Says Yes to Rockwell Medical’s Iron Replacement Drug
January 26, 2015
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3 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Shire’s $5.2 Billion Bet Pays Off as NPS Pharmaceuticals, Inc.'s Natpara Wins Approval
January 26, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Green Lights Daiichi Sankyo’s New Anti-Clotting Drug
January 9, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Novartis AG Submits Two Lung Drugs for FDA Approval; Analysts Question Decision
January 8, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Denies Approval for Actavis’ Hypertension Combo Treatment
December 29, 2014
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Actavis, Adamas Pharmaceuticals Win FDA Approval for Alzheimer’s Drug Namzaric
December 24, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Novo Nordisk A/S’s Weight Management Drug Saxenda
December 24, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Grants Accelerated Approval for Bristol-Myers Squibb Company’s Skin Cancer Drug Opdivo
December 23, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
AstraZeneca PLC Grabs Accelerated FDA Approval for Lynparza
December 22, 2014
 · 
2 min read
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PRESS RELEASES
Press Releases
FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
February 20, 2026
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17 min read
Press Releases
FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
February 20, 2026
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8 min read
Press Releases
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
February 20, 2026
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13 min read
Press Releases
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
February 20, 2026
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13 min read
Press Releases
NexEos Bio Announces FDA Clearance of IND Application to Proceed to Phase II/III Trial of NTX-1024 in Vernal Keratoconjunctivitis
February 19, 2026
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3 min read
Press Releases
Pilatus Biosciences Receives FDA Fast Track Designation for Metabolic Checkpoint Inhibitor PLT012 in Hepatocellular Carcinoma
February 19, 2026
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4 min read
Press Releases
Sibel Health Receives FDA Acceptance into Drug Development Tool Qualification Program for Innovative Cough Monitoring Sensor
February 19, 2026
 · 
5 min read
Press Releases
Dror Ortho-Design Receives 510(k) FDA Clearance for Next-Generation Smile Correction Solution
February 19, 2026
 · 
8 min read
Press Releases
Breath Diagnostics, Inc. Receives FDA Breakthrough Device Designation for OneBreath™ Platform to Aid Pre-Operative Pneumonia Risk Assessment
February 19, 2026
 · 
6 min read
Press Releases
Garetosmab Biologics License Application Accepted for FDA Priority Review for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
February 19, 2026
 · 
12 min read
Press Releases
FDA Clearance Sets Stage for U.S. Commercialization of eyonis® LCS Software as a Medical Device for Lung Cancer Screening; Oran Muduroglu Appointed President of Median eyonis Inc.
February 18, 2026
 · 
8 min read
Press Releases
FDA Grants PMA Approval to LimiFlex(TM) Dynamic Sagittal Tether
February 18, 2026
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3 min read
Press Releases
FDA Approval Granted for Commercial Manufacturing at Rezon Bio’s Warsaw-Duchnice Facility
February 18, 2026
 · 
3 min read
Press Releases
Maestro MEA Platform Powers First Stem Cell Cardiac Safety Assay in FDA ISTAND Program
February 18, 2026
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3 min read
Press Releases
FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens
February 18, 2026
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2 min read
Press Releases
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
February 18, 2026
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26 min read
Press Releases
Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance
February 18, 2026
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4 min read
Press Releases
Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
February 18, 2026
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8 min read
Press Releases
Helsinn announces European Commission approval of AKYNZEO® Oral Suspension
February 18, 2026
 · 
2 min read
Press Releases
FDA Expands U.S. Age Indication for EVO ICL as Long-Term Safety Data Reinforces Market Shift Away From Laser Vision Correction
February 18, 2026
 · 
8 min read
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