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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Questions Merck & Co.'s C. Diff Diarrhea Medication’s Efficacy
June 8, 2016
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Biogen and AbbVie’s Once-Monthly MS Drug Zinbryta
May 31, 2016
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Titan Pharma Receives FDA Approval for the First Ever Implantable Device for Opioid Dependency
May 27, 2016
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Genentech Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years
May 18, 2016
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3 min read
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
 · 
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
 · 
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
 · 
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
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PRESS RELEASES
Press Releases
Femasys Expands Fertility Care Portfolio in Europe with CE Mark Approval for FemHSG™ Catheter
May 13, 2026
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5 min read
Press Releases
Silexion Therapeutics Announces Initiation of GMP Clinical Supply Manufacturing of SIL204 with Leading Global CDMO, and New Approval of Phase 2/3 Trial From Tel Aviv Sourasky Medical Center
May 13, 2026
 · 
7 min read
Press Releases
Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118, a PD-1 x VEGF Bispecific Antibody
May 13, 2026
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3 min read
Press Releases
Arvinas Reports First Quarter 2026 Financial Results and Provides Corporate Update
May 12, 2026
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24 min read
Press Releases
Orion Animal Health receives US FDA approval for Tessie® (tasipimidine oral solution) for the treatment of noise aversion and separation anxiety in dogs
May 12, 2026
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3 min read
Press Releases
ProBio and Curocell Achieve Key CAR-T Milestone with BLA Regulatory Approval and Commercial Readiness
May 11, 2026
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5 min read
Press Releases
LIB Therapeutics Launches LEROCHOL® (lerodalcibep-liga) in the United States with a Patient-First Approach to Access and Affordability
May 11, 2026
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6 min read
Press Releases
Partner Therapeutics Announces FDA Approval of BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher
May 11, 2026
 · 
12 min read
Press Releases
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
May 10, 2026
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2 min read
Press Releases
argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
May 10, 2026
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14 min read
Press Releases
Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell Carcinoma
May 8, 2026
 · 
9 min read
Press Releases
Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults
May 8, 2026
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18 min read
Press Releases
InnoCare Announces Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Sjögren’s Syndrome in China
May 8, 2026
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3 min read
Press Releases
Aspire Biopharma Holdings, Inc. Announces Approval Of Reverse Stock Split Ratio
May 7, 2026
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4 min read
Press Releases
Scienture Secures $11.0 Million in Non-Dilutive Debt Financing to Accelerate Growth of Approved Product Portfolio and Advancement of R&D Pipeline
May 7, 2026
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11 min read
Press Releases
InnoCare Announces Approval of Clinical Trial of Novel CDH7 targeted ADC ICP-B208 in China
May 7, 2026
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3 min read
Press Releases
Avacta presents new comparisons of pre|CISION® payload release vs approved ADCs and AVA6207 dual payload delivery at Science Day 2026
May 6, 2026
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5 min read
Press Releases
Lannett Company, Lanexa Biologics and Sunshine Lake Pharma announce FDA Approval of LANGLARA™ an Interchangeable Biosimilar of Lantus® (insulin glargine)
May 4, 2026
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5 min read
Press Releases
Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies
May 4, 2026
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6 min read
Press Releases
Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations
May 4, 2026
 · 
4 min read
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