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Approvals

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
 · 
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
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
October 10, 2016
 · 
2 min read
Genentech Grows on Promise of 70+ Drug Approvals
Drug Development
Genentech’s Lung Cancer Drug Alecensa Gets 2nd FDA Breakthrough Status
October 4, 2016
 · 
2 min read
Why This Tiny Biotech is Giving Cash to Amgen Researchers
FDA
FDA Clears Amgen Copy of AbbVie’s Blockbuster Humira
September 26, 2016
 · 
3 min read
Did FDA Just Destroy Its Credibility?
FDA
BioPharm Executive: Did the FDA Just Destroy Its Credibility?
September 23, 2016
 · 
5 min read
FDA
Approving A Muscular Dystrophy Drug Exposes A Civil War At The FDA
September 20, 2016
 · 
1 min read
This Is Why Woodcock OKed Sarepta's DMD Drug
FDA
Meet the Powerful Woman Behind the Scenes of Sarepta’s DMD Drug Approval
September 20, 2016
 · 
4 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
 · 
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
 · 
3 min read
Press Releases
ProBio and Curocell Achieve Key CAR-T Milestone with BLA Regulatory Approval and Commercial Readiness
May 11, 2026
 · 
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
 · 
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
 · 
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
 · 
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
 · 
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
 · 
3 min read
Press Releases
Aspire Biopharma Holdings, Inc. Announces Approval Of Reverse Stock Split Ratio
May 7, 2026
 · 
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
 · 
11 min read
Press Releases
InnoCare Announces Approval of Clinical Trial of Novel CDH7 targeted ADC ICP-B208 in China
May 7, 2026
 · 
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
 · 
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
 · 
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
 · 
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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