SUBSCRIBE
SUBSCRIBE

FDA

Antares Pharma Implodes After FDA Responds to Its Xyosted NDA
FDA
Bay Area’s Dynavax Plunges After the FDA Spurns HEPLISAV-B Again
November 14, 2016
 · 
2 min read
5 Biopharma Influencers Likely to Be on Trump’s Transition Team
FDA
Trump Promises to “Reform the FDA” in Post-Election Mission Statement
November 11, 2016
 · 
3 min read
This Is Why Woodcock OKed Sarepta's DMD Drug
FDA
This Is Why Woodcock OKed Sarepta’s DMD Drug
November 4, 2016
 · 
3 min read
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
Load More
PRESS RELEASES
Press Releases
Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial
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
Sight Sciences Reports First Quarter 2026 Financial Results and Raises Full Year 2026 Revenue Guidance
May 7, 2026
 · 
15 min read
Press Releases
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
May 7, 2026
 · 
2 min read
Press Releases
FDA Expands AI Capabilities and Completes Data Platform Consolidation
May 7, 2026
 · 
2 min read
Press Releases
Diakonos Oncology Awarded Fast Track Designation by FDA for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma
May 6, 2026
 · 
3 min read
Press Releases
Partner Therapeutics Announces Receipt of FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma
May 6, 2026
 · 
11 min read
Press Releases
Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer
May 6, 2026
 · 
11 min read
Press Releases
BriaCell Receives FDA Clearance to Initiate Bria-BRES+™ Clinical Study in Breast Cancer
May 6, 2026
 · 
4 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
Azenta Reports Second Quarter Results for Fiscal 2026, Ended March 31, 2026, Updates Full Year Fiscal 2026 Guidance, and Extends Long-Range Plan to 2029
May 6, 2026
 · 
35 min read
Press Releases
Fate Therapeutics Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of FT819
May 5, 2026
 · 
8 min read
Press Releases
FDA Grants Fast Track Designation for CS-1103, a First-in-class Small Molecule to Reverse Acute Intoxication from Fentanyl
May 5, 2026
 · 
2 min read
Press Releases
Nanobiotix Announces Protocol Amendment to Ongoing Global Phase 3 Head and Neck Cancer Study
May 5, 2026
 · 
6 min read
Press Releases
Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial of CK0802 in Steroid-Refractory Graft-versus-Host Disease (GVHD)
May 5, 2026
 · 
8 min read
Press Releases
Opus Genetics Announces FDA Acceptance of OPGx-LCA5 into Rare Disease Evidence Principles (RDEP) Program
May 4, 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
Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen for McCune-Albright Syndrome
May 4, 2026
 · 
7 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
NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDA
May 4, 2026
 · 
9 min read
Load More