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FDA

Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
As Spinoff Rumors Spin, Sanofi’s Cholesterol Drug Praluent Gets Approval in Europe
September 28, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Genentech’s Hemophilia A Drug Gets Breakthrough Designation in Potential $11 Billion Market
September 4, 2015
 · 
2 min read
FDA Approval of Amgen’s Cholesterol Drug Repatha Could Boost Job Growth on East Coast
FDA
FDA Approval of Amgen’s Cholesterol Drug Repatha Could Boost Job Growth on East Coast
August 28, 2015
 · 
2 min read
Biowarfare Company Emergent's Cancer Spinoff Aptevo Therapeutics to Employ 70 - 90 in Seattle
FDA
Sprout to Expand to 200 Employees After FDA Approval of Female Sex-Drive Drug
August 19, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Sprout’s First-Ever Female Libido Drug Comes With Boxed Warning and Controversy
August 19, 2015
 · 
4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Green Lights First 3D Printed Drug From Aprecia
August 3, 2015
 · 
2 min read
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
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PRESS RELEASES
Press Releases
FDA Expands U.S. Age Indication for EVO ICL as Long-Term Safety Data Reinforces Market Shift Away From Laser Vision Correction
February 18, 2026
 · 
8 min read
Press Releases
Beta Bionics Announces Fourth Quarter and Full Year 2025 Financial Results and Introduces Annual Guidance for Full Year 2026
February 18, 2026
 · 
16 min read
Press Releases
Shield Therapeutics Announces FDA Approval of ACCRUFeR®, the First and Only Prescription Oral Iron Therapy Approved for Children Age 10 and Older
February 17, 2026
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2 min read
Press Releases
FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
February 17, 2026
 · 
2 min read
Press Releases
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
 · 
13 min read
Press Releases
Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
February 17, 2026
 · 
1 min read
Press Releases
OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma
February 17, 2026
 · 
1 min read
Press Releases
Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy
February 17, 2026
 · 
10 min read
Press Releases
FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
February 17, 2026
 · 
32 min read
Press Releases
FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)
February 17, 2026
 · 
13 min read
Press Releases
Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average
February 17, 2026
 · 
4 min read
Press Releases
Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL
February 17, 2026
 · 
6 min read
Press Releases
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma
February 17, 2026
 · 
6 min read
Press Releases
Cytokinetics Announces European Commission Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
February 17, 2026
 · 
9 min read
Press Releases
Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study
February 17, 2026
 · 
2 min read
Press Releases
NRx Pharmaceuticals (Nasdaq:NRXP) Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting
February 17, 2026
 · 
5 min read
Press Releases
Cyclerion Therapeutics Announces Progress Toward CYC-126 Phase 2 Proof-of-Concept Study with FDA Feedback and Formation of Clinical Advisory Board
February 17, 2026
 · 
12 min read
Press Releases
Kane Biotech Announces FDA 510(k) Clearance for revyve® Antimicrobial Skin and Wound Cleanser
February 17, 2026
 · 
4 min read
Press Releases
LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System
February 16, 2026
 · 
2 min read
Press Releases
CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial
February 16, 2026
 · 
4 min read
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