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Drug Development
Biopharma Update on the Novel Coronavirus: June 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 10, 2020.
June 10, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: June 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 8, 2020.
June 8, 2020
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3 min read
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BioSpace Editorial Staff
Policy
FDA Action Alert: Viela, Merck, Epizyme, Evoke and Regeneron
The next two weeks are busy ones for the U.S. Food and Drug Administration (FDA). Here’s a look at PDUFA dates for this period.
June 5, 2020
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4 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: June 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 5, 2020.
June 5, 2020
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3 min read
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BioSpace Editorial Staff
lucarista / Shutterstock
FDA
New Roche Diagnostics Device Tests Levels of IL-6 in COVID-19 Patients
Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
June 4, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: June 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 4, 2020.
June 4, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Delays Ruling on Novartis’ Relapsing Multiple Sclerosis Drug Arzerra
On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months.
June 3, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 3, 2020.
June 3, 2020
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4 min read
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BioSpace Editorial Staff
Business
Biopharma Update on the Novel Coronavirus: June 2
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 2, 2020.
June 2, 2020
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4 min read
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BioSpace Editorial Staff
Business
FDA Commissioner Outlines Plans to Improve FDA Post-Pandemic
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn recently gave a speech to the Alliance for a Stronger FDA. In it, he suggested that some of the changes forced on the agency by the COVID-19 pandemic are likely to become permanent.
June 2, 2020
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5 min read
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Mark Terry
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PRESS RELEASES
Press Releases
PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Accelerated Approval
February 20, 2026
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6 min read
Press Releases
Zelluna Receives UK MHRA and Ethics Approval to Initiate ZIMA-101 First-in-Human Clinical Trial
February 20, 2026
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4 min read
Press Releases
Aspire Biopharma Regains Full Compliance with Nasdaq Listing Requirements
February 20, 2026
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5 min read
Press Releases
FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
February 20, 2026
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17 min read
Press Releases
FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
February 20, 2026
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8 min read
Press Releases
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
February 20, 2026
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13 min read
Press Releases
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
February 20, 2026
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13 min read
Press Releases
STRATA Skin Sciences Confirms Nasdaq Delisting
February 19, 2026
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5 min read
Press Releases
PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis
February 19, 2026
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9 min read
Press Releases
NexEos Bio Announces FDA Clearance of IND Application to Proceed to Phase II/III Trial of NTX-1024 in Vernal Keratoconjunctivitis
February 19, 2026
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3 min read
Press Releases
Boehringer Ingelheim Granted Emergency Use Authorization for New World Screwworm Treatments in Dogs and Cats
February 19, 2026
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5 min read
Press Releases
Eisai Maintains Commitment to People Living with Early Alzheimer’s Disease Despite CDA-AMC Draft Recommendation: Patients Deserve Access to Effective Treatment
February 19, 2026
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15 min read
Press Releases
Pilatus Biosciences Receives FDA Fast Track Designation for Metabolic Checkpoint Inhibitor PLT012 in Hepatocellular Carcinoma
February 19, 2026
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4 min read
Press Releases
Sibel Health Receives FDA Acceptance into Drug Development Tool Qualification Program for Innovative Cough Monitoring Sensor
February 19, 2026
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5 min read
Press Releases
Dror Ortho-Design Receives 510(k) FDA Clearance for Next-Generation Smile Correction Solution
February 19, 2026
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8 min read
Press Releases
Breath Diagnostics, Inc. Receives FDA Breakthrough Device Designation for OneBreath™ Platform to Aid Pre-Operative Pneumonia Risk Assessment
February 19, 2026
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6 min read
Press Releases
Garetosmab Biologics License Application Accepted for FDA Priority Review for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
February 19, 2026
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12 min read
Press Releases
FDA Clearance Sets Stage for U.S. Commercialization of eyonis® LCS Software as a Medical Device for Lung Cancer Screening; Oran Muduroglu Appointed President of Median eyonis Inc.
February 18, 2026
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8 min read
Press Releases
FDA Grants PMA Approval to LimiFlex(TM) Dynamic Sagittal Tether
February 18, 2026
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3 min read
Press Releases
ImmunityBio Receives Authorization from the European Commission for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ, Expanding Global Access to 33 Countries
February 18, 2026
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14 min read
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