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Approvals

Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Amgen Beats Sanofi/Regeneron to European Market for Cholesterol Drug, but Race is Still on for U.S. Market
July 21, 2015
 · 
3 min read
Novartis AG Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20%
FDA
Novartis AG Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20%
July 8, 2015
 · 
5 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Vertex Gets FDA Approval for $259K Per Year CF Drug
July 6, 2015
 · 
3 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Panel Backs Amgen’s Repatha, But With Strings Attached
June 11, 2015
 · 
4 min read
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
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PRESS RELEASES
Press Releases
European Commission Approves Pfizer’s HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors
May 13, 2026
 · 
16 min read
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
 · 
3 min read
Press Releases
Arvinas Reports First Quarter 2026 Financial Results and Provides Corporate Update
May 12, 2026
 · 
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
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