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Drug Development
Biopharma Update on the Novel Coronavirus: April 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
April 27, 2020
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7 min read
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BioSpace Editorial Staff
FDA
FDA Approves Sanofi’s Meningococcal Meningitis Vaccine
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
April 24, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: April 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
April 24, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
April 23, 2020
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5 min read
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BioSpace Editorial Staff
Chronic lymphocytic leukemia
FDA
Imbruvica-Rituximab Combo Approved by FDA for Chronic Lymphocytic Leukemia
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
April 22, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
April 22, 2020
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5 min read
 · 
BioSpace Editorial Staff
FDA
LabCorp’s COVID-19 At-Home Test Kit Approved for Emergency Use
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
April 21, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
April 21, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
April 20, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Incyte’s Pemazyre for Rare Bile Duct Cancer
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
April 20, 2020
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3 min read
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Mark Terry
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PRESS RELEASES
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
Press Releases
VectorY Therapeutics Receives U.K. MHRA Authorization and EMA Approval to Initiate Phase 1/2 PIONEER-ALS Clinical Trial of VTx-002 in People Living with Amyotrophic Lateral Sclerosis (ALS)
April 28, 2026
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3 min read
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