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Regulatory

TARPEYO is the first FDA-approved drug for immunog
FDA
Seattle Genetics’ Tukysa Earns FDA Approval for HER2+ Breast Cancer
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
April 20, 2020
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3 min read
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Mark Terry
FDA
FDA Action Alert: Sanofi, Neurocrine, Correvio and United
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
April 17, 2020
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3 min read
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Mark Terry
Policy
FDA Prioritizing COVID-19, but Continuing Normal Routine as Much as Possible
The agency issued a statement saying that it will continue its activities, such as reviewing new drug applications and clinical trial, both COVID-19 and non-COVID-19, applications, “as we do everything possible to maintain continuity of operations in a very dynamic situation.”
April 17, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
April 17, 2020
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6 min read
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BioSpace Editorial Staff
Policy
GenSight Biologics on Track to Submit LUMEVOQ® for European Approval in September 2020 Following Pre-Submission Meeting with EMA
GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announces the completion of the pre-submission meeting with the European Medicines Agency for the Company’s lead product LUMEVOQ®.
April 17, 2020
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6 min read
FDA
FDA Gives UroGen’s Jelmyto Expedited Approval for Urothelial Cancer
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
April 16, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.
April 16, 2020
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8 min read
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BioSpace Editorial Staff
FDA
FDA Approves Use of Ortho’s High-Throughput, Automated COVID-19 Antibody Test
Antibody tests, also called serological tests, test if the individual has been exposed to SARS-CoV-2, the novel coronavirus that causes COVID-19.
April 15, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
April 14, 2020
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6 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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