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FDA

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Approves First-Ever Treatment for Spinal Muscular Atrophy; Ionis Pharma, Biogen Seal Victory
December 27, 2016
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Drug Development
Latest Deaths in Juno Trial Puts Unwanted Limelight on the FDA
November 28, 2016
 · 
2 min read
FDA
President Elect Donald Trump And FDA
November 14, 2016
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1 min read
Antares Pharma Implodes After FDA Responds to Its Xyosted NDA
FDA
Bay Area’s Dynavax Plunges After the FDA Spurns HEPLISAV-B Again
November 14, 2016
 · 
2 min read
5 Biopharma Influencers Likely to Be on Trump’s Transition Team
FDA
Trump Promises to “Reform the FDA” in Post-Election Mission Statement
November 11, 2016
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3 min read
This Is Why Woodcock OKed Sarepta's DMD Drug
FDA
This Is Why Woodcock OKed Sarepta’s DMD Drug
November 4, 2016
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Drug Development
FDA Slaps Partial Hold on Bay Area Firm Aduro Biotech’s Cancer Vaccine Trial
October 24, 2016
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Sarepta Gets No Love From the FDA’s New Drugs Director
October 20, 2016
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3 min read
FDA
Genentech’s Tecentriq Wins Second Approval of the Year, This Time for Lung Cancer
October 19, 2016
 · 
11 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
PTC Therapeutics Tanks After the FDA Denies DMD Drug Translarna Again
October 17, 2016
 · 
3 min read
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PRESS RELEASES
Press Releases
Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
January 23, 2026
 · 
5 min read
Press Releases
OneMedNet Real-World Data Supports FDA 510(k) Clearance of AI-Powered Scaida BrainCT-ICH Software
January 23, 2026
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5 min read
Press Releases
Polyrizon Advances Regulatory Path with Initiation of Usability Study Program for NASARIX™ Allergy Blocker
January 23, 2026
 · 
4 min read
Press Releases
Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01
January 22, 2026
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8 min read
Press Releases
AEON Biopharma Reports BPD Type 2a Meeting with FDA and Shareholder Approval of the November Transactions
January 22, 2026
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4 min read
Press Releases
UPDATE - BPGbio Receives FDA Orphan Drug Designation for BPM31510 for the Treatment of Primary CoQ10 Deficiency
January 22, 2026
 · 
3 min read
Press Releases
INTENT Biologics Receives FDA Agreement Granting a Full Waiver for its Pediatric Study Plan for PEP Biologic™ in Advanced Wound Care
January 22, 2026
 · 
3 min read
Press Releases
OSE Immunotherapeutics Welcomes FDA Orphan Drug Designation Granted to Pegrizeprument (VEL-101)
January 22, 2026
 · 
4 min read
Press Releases
Athos Therapeutics Receives US FDA Authorization to Begin Multi-Center Phase 2 Clinical Trial of ATH-063 in Patients with Ulcerative Colitis
January 22, 2026
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4 min read
Press Releases
NEOK Bio Receives FDA IND Approval for NEOK001, A First-In-Class B7-H3/ROR1 Bispecific ADC for Treatment of Solid Tumor Cancers
January 22, 2026
 · 
2 min read
Press Releases
Opna Bio Announces Orphan Drug Designation Granted to OPN-2853 (Zavabresib) for the Treatment of Myelofibrosis
January 22, 2026
 · 
2 min read
Press Releases
Pegrizeprument Granted Orphan Drug Designation for Prevention of Organ Rejection in Patients Receiving a Liver Transplant
January 22, 2026
 · 
3 min read
Press Releases
SONOMOTION ANNOUNCES FDA CLEARANCE FOR ITS BREAK WAVE™ LITHOTRIPSY DEVICE FOR TREATMENT OF KIDNEY STONES
January 22, 2026
 · 
2 min read
Press Releases
Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI
January 22, 2026
 · 
7 min read
Press Releases
Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain
January 22, 2026
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4 min read
Press Releases
IntraBio Receives European Commission Approval of AQNEURSA® for the Treatment of Niemann-Pick Type C Disease
January 21, 2026
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7 min read
Press Releases
Truvian Health Receives another FDA Clearance – for Complete Blood Count (CBC) on TruVerus™
January 21, 2026
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4 min read
Press Releases
U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma
January 21, 2026
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4 min read
Press Releases
DAWNZERA™ (donidalorsen) approved in the European Union for hereditary angioedema (HAE)
January 21, 2026
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5 min read
Press Releases
SCYNEXIS Receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designations for SCY-247
January 21, 2026
 · 
6 min read
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