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FDA
Stanford Serology Test: Stanford Joins List of Organizations Offering COVID-19 Antibody Testing
The Stanford serology test provides results in two to three days and Stanford Health Care can test 500 samples per day. Know what more it has to offer.
April 13, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.
April 10, 2020
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7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.
April 9, 2020
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9 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Pfizer’s Braftovi Plus Cetuximab for Colorectal Cancer with BRAF Mutations
“We are pleased by the FDA’s approval of Braftovi in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
April 9, 2020
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2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 8, 2020.
April 8, 2020
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7 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 7, 2020.
April 7, 2020
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6 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 6, 2020.
April 6, 2020
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6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020.
April 3, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves 1st COVID-19 Antibody Test
The U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
April 3, 2020
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3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 1, 2020.
April 1, 2020
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8 min read
 · 
BioSpace Editorial Staff
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PRESS RELEASES
Press Releases
U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir
April 29, 2026
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12 min read
Press Releases
Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid Tumors
April 29, 2026
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6 min read
Press Releases
Expression Therapeutics Receives FDA Fast Track and Rare Pediatric Disease Designations for Investigational Stem Cell Therapy for Hemophilia A
April 29, 2026
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3 min read
Press Releases
Norgine announces European Commission Marketing Authorisation for XOLREMDI® (mavorixafor), the first authorised treatment for patients with WHIM syndrome in the European Union
April 29, 2026
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5 min read
Press Releases
U.S. FDA Grants Priority Review to BeOne Medicines’ TEVIMBRA in First-Line HER2+ GEA
April 29, 2026
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9 min read
Press Releases
Chest Wall Innovations Receives FDA 510(k) Clearance for PC Fix Rib Fixation System
April 29, 2026
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1 min read
Press Releases
enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve
April 29, 2026
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6 min read
Press Releases
CMR Surgical Submits 510(k) Application to U.S. FDA to Expand Versius Plus™ into Gynecology
April 29, 2026
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6 min read
Press Releases
Laguna Announces FDA Clearance of IND Application for LGNA-100, a Novel γδ T Cell Activator for High-Risk Pediatric Leukemias
April 29, 2026
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3 min read
Press Releases
PreludeDx Receives FDA Breakthrough Device Designation for AidaBREAST® - Early-Stage Invasive Breast Cancer Assay
April 29, 2026
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3 min read
Press Releases
European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe
April 29, 2026
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8 min read
Press Releases
Canada becomes the first G7 country to approve a generic version of semaglutide
April 29, 2026
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1 min read
Press Releases
Organogenesis Completes Rolling Submission of Biologics License Application for ReNu®
April 29, 2026
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4 min read
Press Releases
Paradigm Health Announces Collaboration with the FDA to Transform Regulatory Review of Clinical Trial Data
April 29, 2026
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4 min read
Press Releases
FDA Announces Major Steps to Implement Real-Time Clinical Trials
April 29, 2026
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3 min read
Press Releases
Orca Bio Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies
April 28, 2026
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3 min read
Press Releases
Vensica Medical Receives FDA IND Clearance to Initiate Phase 2 Study of ViXe, Its Needle-Free Xeomin® Delivery System for Overactive Bladder
April 28, 2026
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2 min read
Press Releases
Olympus Receives FDA Clearance for POWERSEAL™ Open Extended Jaw Device
April 28, 2026
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3 min read
Press Releases
Abbott receives FDA clearance and CE Mark for next-generation Ultreon™ 3.0 AI-powered coronary imaging platform
April 28, 2026
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5 min read
Press Releases
C-Ray Therapeutics Receives FDA Acceptance of Type II Drug Master File for Copper-64 (Cu-64)
April 28, 2026
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3 min read
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