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Regulatory

Drug Development
Biopharma Update on the Novel Coronavirus: September 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.
September 22, 2020
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5 min read
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BioSpace Editorial Staff
Policy
FDA Accepts BLA for bluebird and BMS’ Multiple Myeloma CAR-T Treatment
Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review.
September 22, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
September 21, 2020
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2 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
September 17, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Orphazyme’s Rare Lipid Disorder Drug Arimoclomol Gets Priority Review from the FDA
Arimoclomol will be reviewed under Priority Review with a PDUFA date of March 17, 2021. Here’s more about it.
September 16, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: September 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
September 16, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
September 14, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
September 10, 2020
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2 min read
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BioSpace Editorial Staff
Treatment of asthma coming very soon.
FDA
GSK’s Trelegy Ellipta Wins Approval as Treatment of Asthma
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.
September 10, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
September 8, 2020
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4 min read
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BioSpace Editorial Staff
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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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