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FDA

FDA
Chiasma Chief Says Firm May Challenge FDA Over Rare-Disease Drug Rejection
May 12, 2016
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2 min read
FDA
Betting Intensifies Over Sarepta’s DMD Drug
May 6, 2016
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Sarepta Craters as the FDA Releases Documents Ahead of Monday’s DMD Drug Hearing
April 21, 2016
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
36 DMD Experts Send Letter to the FDA Urging Approval of Sarepta’s Drug
March 22, 2016
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4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Roche’s Multiple Sclerosis Drug Gets Breakthrough Status, Likely to Haunt Biogen
February 17, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AstraZeneca PLC Continues Its Immuno-Oncology Roll, Durvalumab Gets Breathrough Designation for Bladder Cancer
February 17, 2016
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves AVANIR New Migraine Treatment With Unique Inhalant Delivery System
January 29, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Actelion’s Uptravi Received FDA Approval, to Enter U.S. Market in January
December 22, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Investors Elated as Amgen Wins FDA Approval for First-of-Its-Kind Cancer Killing Virus Drug
October 28, 2015
 · 
3 min read
Drug Development
FDA Designates Pfizer’s Acute Lymphoblastic Leukemia Drug Breakthrough Status
October 19, 2015
 · 
7 min read
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PRESS RELEASES
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
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8 min read
Press Releases
Beta Bionics Announces Fourth Quarter and Full Year 2025 Financial Results and Introduces Annual Guidance for Full Year 2026
February 18, 2026
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16 min read
Press Releases
Shield Therapeutics Announces FDA Approval of ACCRUFeR®, the First and Only Prescription Oral Iron Therapy Approved for Children Age 10 and Older
February 17, 2026
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2 min read
Press Releases
FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
February 17, 2026
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2 min read
Press Releases
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
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13 min read
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
 · 
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
 · 
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
 · 
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
 · 
4 min read
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