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FDA
Karyopharm’s Xpovio Wins Second FDA Approval for DLBCL Treatment
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
June 23, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 22, 2020.
June 22, 2020
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3 min read
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BioSpace Editorial Staff
FDA
FDA Approves Bone-Softening Disorder Treatment Crysvita
Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
June 19, 2020
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2 min read
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Alex Keown
FDA has finally approved tavneos for ANCA Vasculit
FDA
Epizyme’s Tazverik Picks Up Its Second FDA Approval of 2020
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
June 19, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
June 18, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Second Biomarker-Specific Indication for Merck’s Keytruda
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
June 17, 2020
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2 min read
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Alex Keown
Uplizna got green signal from FDA
FDA
FDA Greenlights Two Novartis Drugs, Including First for Adult-Onset Still’s Disease
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
June 17, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 17, 2020.
June 16, 2020
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5 min read
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BioSpace Editorial Staff
REC Stock Footage / Shutterstock
FDA
FDA Approves Akili’s Therapeutic Video Game for ADHD
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
June 16, 2020
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3 min read
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Mark Terry
FDA
Jazz Pharma Gets Approval for Zepzelca in the U.S. for Aggressive Lung Cancer
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
June 16, 2020
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3 min read
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Mark Terry
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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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