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Approvals

M&A Speculation Begins as Sarepta CEO Puts In His Notice
FDA
Victory at Last! Sarepta Stock Doubles as the FDA Finally Approves DMD Drug
September 19, 2016
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Clovis Oncology Stock Jumps as FDA Skips Review Panel for New Cancer Drug
September 9, 2016
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Another Celgene Bet Pays Off as Agios Eyes Early Approval of Leukemia Drug
September 7, 2016
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2 min read
Why This Tiny Biotech is Giving Cash to Amgen Researchers
FDA
Amgen Remains Hush-Hush Over FDA Rejection of Parsabiv
August 25, 2016
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Bay Area’s Portola Plummets as FDA Rejects AndexXa NDA
August 18, 2016
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3 min read
With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.
FDA
With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.
July 28, 2016
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co.'s C. Diff Drug, New PDUFA Date Set
July 22, 2016
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Opko Health Rockets on FDA Approval of Rayaldee Four Months Ahead of PDUFA Date
June 21, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Shire Nabs Breakthrough Tags for Drug to Treat Rare Gastrointestinal Conditions
June 13, 2016
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3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
Pfizer Quietly Raised Drug Prices By an Average of 8.8% Last Week
June 10, 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
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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
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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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