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FDA

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Genentech Wins Breakthrough Nod From FDA for Systemic Sclerosis Treatment
June 10, 2015
 · 
4 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Advisors Back Regeneron, Sanofi’s New Heart Drug With Limits
June 10, 2015
 · 
4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
FDA Grants Breakthrough Designation to Genzyme’s Experimental ASMD Treatment
June 4, 2015
 · 
2 min read
Gilead’s Hep B Trial Failure Will Inspire M&A Activity, Say Analysts
FDA
Rapamune, Pfizer’s Branding-Troubled Drug, Gets FDA Approval for Rare Lung Disease
May 29, 2015
 · 
3 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Drug Development
Heart-Stopping Morning Leads to Vertex Rise As FDA News Sees Positives
May 8, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AbbVie, Genentech Leukemia Drug Wins Breakthrough Status Tag
May 7, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Business
AcelRx Crashes as the FDA Rejects Request for Meeting on Pain Drug Device
May 4, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
GlaxoSmithKline Slips as FDA Approves Asthma Drug for Adults, Not Younger Patients
May 1, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amgen’s T-Vec Cancer Therapy Gets FDA Panel OK
April 30, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Kythera Grabs FDA Approval for Chin Fat-Busting Drug
April 30, 2015
 · 
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
 · 
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
 · 
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
 · 
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
 · 
4 min read
Press Releases
IntraBio Receives European Commission Approval of AQNEURSA® for the Treatment of Niemann-Pick Type C Disease
January 21, 2026
 · 
7 min read
Press Releases
Truvian Health Receives another FDA Clearance – for Complete Blood Count (CBC) on TruVerus™
January 21, 2026
 · 
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
 · 
4 min read
Press Releases
DAWNZERA™ (donidalorsen) approved in the European Union for hereditary angioedema (HAE)
January 21, 2026
 · 
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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