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Approvals

FDA
ViiV’s Tivicay Approved for Children as Young as 4 Weeks with HIV
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV.
June 15, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: June 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.
June 15, 2020
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3 min read
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BioSpace Editorial Staff
Uplizna got green signal from FDA
FDA
FDA Greenlight’s Viela Bio’s Uplizna for Rare Neuroinflammatory Autoimmune Disorder
The FDA approved Viela Bio’s Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive. About 80% of all NMOSD patients test positive for anti-AQP4 antibodies.
June 12, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: June 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 12, 2020.
June 11, 2020
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4 min read
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BioSpace Editorial Staff
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
 · 
BioSpace Editorial Staff
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
 · 
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
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PRESS RELEASES
Press Releases
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
May 10, 2026
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2 min read
Press Releases
argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
May 10, 2026
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14 min read
Press Releases
Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell Carcinoma
May 8, 2026
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9 min read
Press Releases
Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults
May 8, 2026
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18 min read
Press Releases
InnoCare Announces Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Sjögren’s Syndrome in China
May 8, 2026
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3 min read
Press Releases
Aspire Biopharma Holdings, Inc. Announces Approval Of Reverse Stock Split Ratio
May 7, 2026
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4 min read
Press Releases
Scienture Secures $11.0 Million in Non-Dilutive Debt Financing to Accelerate Growth of Approved Product Portfolio and Advancement of R&D Pipeline
May 7, 2026
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11 min read
Press Releases
InnoCare Announces Approval of Clinical Trial of Novel CDH7 targeted ADC ICP-B208 in China
May 7, 2026
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3 min read
Press Releases
Avacta presents new comparisons of pre|CISION® payload release vs approved ADCs and AVA6207 dual payload delivery at Science Day 2026
May 6, 2026
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5 min read
Press Releases
Lannett Company, Lanexa Biologics and Sunshine Lake Pharma announce FDA Approval of LANGLARA™ an Interchangeable Biosimilar of Lantus® (insulin glargine)
May 4, 2026
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5 min read
Press Releases
Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies
May 4, 2026
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6 min read
Press Releases
Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations
May 4, 2026
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4 min read
Press Releases
ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older
May 4, 2026
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6 min read
Press Releases
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease
May 4, 2026
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14 min read
Press Releases
InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System
May 4, 2026
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6 min read
Press Releases
Apotex becomes the first Canadian‑based pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic®
May 4, 2026
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3 min read
Press Releases
Novartis receives Health Canada approval for Fabhalta® oral treatment for adults with C3G
May 4, 2026
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4 min read
Press Releases
Arvinas Announces FDA Approval of VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer
May 3, 2026
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13 min read
Press Releases
Arrowhead Pharmaceuticals Receives TGA Approval of REDEMPLO® (plozasiran) in Australia, Expanding Global Access for Patients with Familial Chylomicronemia Syndrome (FCS)
May 1, 2026
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10 min read
Press Releases
Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought Leader
May 1, 2026
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15 min read
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