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FDA

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
Drug Development
Biopharma Update on the Novel Coronavirus: September 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
September 3, 2020
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3 min read
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BioSpace Editorial Staff
FDA
FDA Approves New HIV-1/HIV-2 Qualitative Test from Roche
This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2.
September 2, 2020
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2 min read
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Krystle Vermes
Drug Development
At Least 4 Vaccine Candidates Backed by U.S. Government Predicted to Fail, Analytics Group Says
The U.S. government has financially backed the development of six different vaccine candidates aimed at the novel coronavirus. Although billions of dollars have been appropriated to the pandemic, at least four of those potential preventative treatments are predicted to fail in the clinic.
September 2, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 2
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 2, 2020.
September 1, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: August 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 31, 2020.
August 31, 2020
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2 min read
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BioSpace Editorial Staff
FoundationOne Liquid CDx got green flag from FDA.
FDA
FoundationOne Liquid CDx Wins Approval for Comprehensive Pan-Tumor Liquid Biopsy
With a new regulatory approval in hand for its FoundationOne Liquid CDx, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.
August 27, 2020
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2 min read
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Alex Keown
FDA
FDA Approves New Acne Treatment Winlevi with New Mechanism of Action in 40 Years
The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi. Let’s look at how this new acne treatment was developed.
August 27, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
August 25, 2020
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4 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: August 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.
August 24, 2020
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2 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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