SUBSCRIBE
SUBSCRIBE

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
Load More
PRESS RELEASES
Press Releases
Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
January 23, 2026
 · 
5 min read
Press Releases
OneMedNet Real-World Data Supports FDA 510(k) Clearance of AI-Powered Scaida BrainCT-ICH Software
January 23, 2026
 · 
5 min read
Press Releases
Polyrizon Advances Regulatory Path with Initiation of Usability Study Program for NASARIX™ Allergy Blocker
January 23, 2026
 · 
4 min read
Press Releases
Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01
January 22, 2026
 · 
8 min read
Press Releases
AEON Biopharma Reports BPD Type 2a Meeting with FDA and Shareholder Approval of the November Transactions
January 22, 2026
 · 
4 min read
Press Releases
UPDATE - BPGbio Receives FDA Orphan Drug Designation for BPM31510 for the Treatment of Primary CoQ10 Deficiency
January 22, 2026
 · 
3 min read
Press Releases
INTENT Biologics Receives FDA Agreement Granting a Full Waiver for its Pediatric Study Plan for PEP Biologic™ in Advanced Wound Care
January 22, 2026
 · 
3 min read
Press Releases
OSE Immunotherapeutics Welcomes FDA Orphan Drug Designation Granted to Pegrizeprument (VEL-101)
January 22, 2026
 · 
4 min read
Press Releases
Athos Therapeutics Receives US FDA Authorization to Begin Multi-Center Phase 2 Clinical Trial of ATH-063 in Patients with Ulcerative Colitis
January 22, 2026
 · 
4 min read
Press Releases
NEOK Bio Receives FDA IND Approval for NEOK001, A First-In-Class B7-H3/ROR1 Bispecific ADC for Treatment of Solid Tumor Cancers
January 22, 2026
 · 
2 min read
Press Releases
Opna Bio Announces Orphan Drug Designation Granted to OPN-2853 (Zavabresib) for the Treatment of Myelofibrosis
January 22, 2026
 · 
2 min read
Press Releases
Pegrizeprument Granted Orphan Drug Designation for Prevention of Organ Rejection in Patients Receiving a Liver Transplant
January 22, 2026
 · 
3 min read
Press Releases
SONOMOTION ANNOUNCES FDA CLEARANCE FOR ITS BREAK WAVE™ LITHOTRIPSY DEVICE FOR TREATMENT OF KIDNEY STONES
January 22, 2026
 · 
2 min read
Press Releases
Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI
January 22, 2026
 · 
7 min read
Press Releases
Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain
January 22, 2026
 · 
4 min read
Press Releases
IntraBio Receives European Commission Approval of AQNEURSA® for the Treatment of Niemann-Pick Type C Disease
January 21, 2026
 · 
7 min read
Press Releases
Truvian Health Receives another FDA Clearance – for Complete Blood Count (CBC) on TruVerus™
January 21, 2026
 · 
4 min read
Press Releases
U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma
January 21, 2026
 · 
4 min read
Press Releases
DAWNZERA™ (donidalorsen) approved in the European Union for hereditary angioedema (HAE)
January 21, 2026
 · 
5 min read
Press Releases
SCYNEXIS Receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designations for SCY-247
January 21, 2026
 · 
6 min read
Load More