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FDA

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Merck & Co.'s Immuno-Oncology Star Racks Up Two New Bladder Cancer Approvals
May 19, 2017
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3 min read
FDA
Faster FDA Approvals? Not So Fast: 1 Out of 3 New Drugs Had Safety Problems No One Knew About
May 10, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Mitsubishi Tanabe Wins FDA Approval for Radicava, the First New ALS Drug in 22 Years
May 8, 2017
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2 min read
AstraZeneca PLC Offloads Remaining Anesthetics Portfolio in $766 Million Deal
FDA
AstraZeneca PLC Hits Milestone With Approval of Potential Bladder Cancer Blockbuster
May 2, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Takeda’s $5 Billion Bet on Ariad Pays Off With Accelerated Approval of Lung Cancer Med
May 1, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Wowsers! FDA Approves BioMarin’s Brineura, the First Drug for Batten Disease
April 28, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Just Rejected Eli Lilly, Incyte’s Rheumatoid Arthritis Drug Baricitinib
April 14, 2017
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Nothing’s Gonna Stop Neurocrine Now: Shares Jumped on FDA Approval of the First and Only Drug to Treat Tardive Dyskinesia for Adults
April 12, 2017
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3 min read
FDA
Gilead Release: FDA Approves New Indications For Harvoni And Sovaldi In Pediatric Patients 12 Years And Older With Chronic Hepatitis C Infection
April 7, 2017
 · 
10 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases
April 6, 2017
 · 
2 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
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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
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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
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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
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3 min read
Press Releases
OSE Immunotherapeutics Welcomes FDA Orphan Drug Designation Granted to Pegrizeprument (VEL-101)
January 22, 2026
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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
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2 min read
Press Releases
Opna Bio Announces Orphan Drug Designation Granted to OPN-2853 (Zavabresib) for the Treatment of Myelofibrosis
January 22, 2026
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2 min read
Press Releases
Pegrizeprument Granted Orphan Drug Designation for Prevention of Organ Rejection in Patients Receiving a Liver Transplant
January 22, 2026
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3 min read
Press Releases
SONOMOTION ANNOUNCES FDA CLEARANCE FOR ITS BREAK WAVE™ LITHOTRIPSY DEVICE FOR TREATMENT OF KIDNEY STONES
January 22, 2026
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2 min read
Press Releases
Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI
January 22, 2026
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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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