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Approvals

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FDA
FDA Approves New 6-Week Dosing for Keytruda for All Approved Adult Indications
The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
April 29, 2020
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2 min read
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Alex Keown
FDA approved Ascendis Pharma’s Skytrofa.
FDA
Neurocrine Biosciences Receives FDA Approval for Ongentys, Opts to Delay Launch
Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease.
April 28, 2020
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3 min read
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Krystle Vermes
Policy
Biopharma Update on the Novel Coronavirus: April 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 28, 2020.
April 28, 2020
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6 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
April 27, 2020
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7 min read
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BioSpace Editorial Staff
FDA
FDA Approves Sanofi’s Meningococcal Meningitis Vaccine
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
April 24, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: April 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
April 24, 2020
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7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
April 23, 2020
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5 min read
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BioSpace Editorial Staff
Chronic lymphocytic leukemia
FDA
Imbruvica-Rituximab Combo Approved by FDA for Chronic Lymphocytic Leukemia
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
April 22, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
April 22, 2020
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5 min read
 · 
BioSpace Editorial Staff
FDA
LabCorp’s COVID-19 At-Home Test Kit Approved for Emergency Use
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
April 21, 2020
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3 min read
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Mark Terry
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PRESS RELEASES
FDA
MAGNESIUM DEVELOPMENT COMPANY ANNOUNCES FDA BREAKTHROUGH DEVICE DESIGNATION FOR RESORBABLE HC SCREW
January 24, 2022
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2 min read
FDA
FDA Approves Veklury® (Remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
January 21, 2022
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14 min read
FDA
U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis
January 21, 2022
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14 min read
FDA
Applied DNA Submits Request for Emergency Use Authorization to FDA for Linea™ 2.0 COVID-19 Assay and Linea™ Unsupervised At-Home Sample Collection Kit
January 21, 2022
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6 min read
FDA
Arch Oncology Receives U.S. FDA Orphan Drug Designation for AO-176, a Next-Generation Anti-CD47 IgG2 Antibody, for the Treatment of Multiple Myeloma
January 21, 2022
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2 min read
FDA
Aptorum Group Receives FDA Orphan Drug Designation for its SACT-1 Repurposed Drug For The Treatment of Neuroblastoma
January 20, 2022
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5 min read
FDA
Palleon Pharmaceuticals Announces IND Clearance for First-in-Class Cancer Immunotherapy Leveraging Glyco-Immunology
January 20, 2022
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1 min read
FDA
Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon
January 20, 2022
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10 min read
FDA
AN2 Therapeutics Provides Regulatory Update and Plan to Initiate Clinical Development for Epetraborole Targeting NTM Lung Disease
January 20, 2022
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1 min read
FDA
CASI PHARMACEUTICALS PARTNER, BIOINVENT, ANNOUNCES BI -1206 GRANTED ORPHAN DRUG DESIGNATION BY THE U.S. FDA FOR THE TREATMENT OF PATIENTS WITH FOLLICULAR LYMPHOMA
January 20, 2022
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4 min read
FDA
Senhwa’s Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer
January 20, 2022
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3 min read
FDA
Capillary Biomedical Receives FDA Approval to Begin Pivotal Trial of Its SteadiFlow Seven-Day-Wear Infusion Set Technology
January 19, 2022
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3 min read
FDA
Neurophth Therapeutics Receives IND Clearance to Initiate Clinical Trial for China AAV-ND4 Gene Therapy NR082 in Leber Hereditary Optic Neuropathy
January 19, 2022
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6 min read
FDA
Pathogenomix granted FDA Breakthrough Device Designation
January 19, 2022
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5 min read
FDA
CytomX Therapeutics Announces FDA Clearance of Investigational New Drug Application for CX-904 for the Treatment of Advanced Solid Tumors
January 19, 2022
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6 min read
FDA
Nevro Announces FDA Approval for Expanded Labeling for its 10 kHz High Frequency Spinal Cord Stimulation System for Treatment of Non-Surgical Refractory Back Pain (NSRBP)
January 19, 2022
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5 min read
Drug Development
Kinnate Biopharma Inc. Announces FDA Clearance of Investigational Drug Application for KIN-3248Planned initiation of Phase 1 clinical trial for KIN-3248 in 1H2022
January 18, 2022
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6 min read
FDA
PolarityTE Announces U.S. FDA Approval of IND for Pivotal Phase 3 Study of SkinTE® to Support Chronic Cutaneous Ulcer Indication
January 18, 2022
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4 min read
FDA
Celcuity Receives FDA Fast Track Designation for Gedatolisib in HR+ / HER2- Metastatic Breast Cancer and Provides Corporate Update
January 18, 2022
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6 min read
FDA
Antares Pharma Receives FDA Fast Track Designation for ATRS-1902 for Adrenal Crisis Rescue
January 18, 2022
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5 min read
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