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FDA
FDA Cancels Emergency Use Authorization of Hydroxychloroquine for COVID-19
The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.
June 15, 2020
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3 min read
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Mark Terry
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
 · 
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
 · 
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
 · 
4 min read
 · 
BioSpace Editorial Staff
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PRESS RELEASES
Press Releases
ImmunityBio Advances First-Line BCG Naive NMIBC Program with Enrollment Exceeding Expectations and Positive Interim Analysis for ANKTIVA® Plus BCG
January 16, 2026
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9 min read
Press Releases
CASI Pharmaceuticals Announces Approval of Clinical Trial Application by China NMPA for Phase 1 / 2 Study of CID-103 for Renal Allograft Antibody-Mediated Rejection (AMR)
January 16, 2026
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7 min read
Press Releases
Santhera Receives Swissmedic Approval of AGAMREE® (Vamorolone) for the Treatment of Duchenne Muscular Dystrophy
January 16, 2026
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4 min read
Press Releases
Press Release: Myqorzo and Redemplo approved in China
January 16, 2026
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8 min read
Press Releases
Hyundai Bioscience Confirms Entry into U.S. FDA Phase 2 Trials for Broad-Spectrum Antiviral ‘XAFTY’ Following 2026 Biotech Showcase Consensus
January 15, 2026
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3 min read
Press Releases
Adolore BioTherapeutics Announces FDA Orphan Drug Designation for its Kv7-activating rdHSV-CA8* Therapy in the Treatment of Erythromelalgia
January 15, 2026
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7 min read
Press Releases
VizMark Secures FDA 510k Clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging
January 15, 2026
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1 min read
Press Releases
FDA Approves Updated Label for Miach Orthopaedics’ BEAR® Implant to Include Significantly Lower Risk of Osteoarthritis
January 15, 2026
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5 min read
Press Releases
Emergent BioSolutions Receives U.S. FDA Approval on Supplemental New Drug Application for NARCAN® Nasal Spray to be Packaged in a New Carrying Case, Making Life-Saving Naloxone More Accessible for Everyday Preparedness
January 15, 2026
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5 min read
Press Releases
NRx Pharmaceuticals (Nasdaq:NRXP) Announces 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA in Support of NRX-100 Approval
January 15, 2026
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6 min read
Press Releases
Routine FDA Inspection Reveals Zero Findings for Univo IRB
January 14, 2026
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1 min read
Press Releases
Vy Spine Announces FDA Clearance for VyBrate VBR System
January 14, 2026
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2 min read
Press Releases
Travere Therapeutics Announces FDA Extends Review of sNDA for FILSPARI® (sparsentan) in FSGS
January 14, 2026
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16 min read
Press Releases
FDA Files Rejoni’s Juveena® Hydrogel System PMA for the Prevention of Intrauterine Adhesions
January 14, 2026
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1 min read
Press Releases
U.S. FDA grants Ipsen’s IPN60340 (ICT01) Breakthrough Therapy Designation in first line unfit Acute Myeloid Leukemia
January 14, 2026
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8 min read
Press Releases
Cerapedics’ PearlMatrix P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator, Now Approved for Expanded Indications for Use
January 14, 2026
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6 min read
Press Releases
Revance and Teoxane Announce the FDA Approval of RHA® Dynamic Volume for Midface Contour Deficiencies
January 14, 2026
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10 min read
Press Releases
Bionpharma Inc. Receives USFDA Approval for Etravirine Tablets Developed in Collaboration with STEERLife
January 14, 2026
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4 min read
Press Releases
AliveCor Announces FDA Clearance of New Cardiac Determinations for Kardia 12L ECG System, Bringing Total to 39
January 14, 2026
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4 min read
Press Releases
FDA Confirms a PDUFA Goal Date of August 30, 2026 for the sBLA Submission of Ropeginterferon Alfa-2b-njft in Essential Thrombocythemia (ET)
January 13, 2026
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6 min read
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