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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
201 Results
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FDA
FDA Panel Supports Narrow Lynparza Label for Prostate Cancer
The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.
May 1, 2023
·
3 min read
·
Tristan Manalac
Deals
Astellas to Buy Iveric Bio for $5.9B in Age-Related Blindness Play
Japanese biopharma scoops up Iveric’s investigational drug for age-related blindness disease. The drug, which trails Apellis’ Syfovre, is awaiting FDA approval with a decision expected by August.
May 1, 2023
·
2 min read
·
Kate Goodwin
FDA
FDA Greenlights First Bi-Monthly Injectable for Schizophrenia, Bipolar 1 Disorder
Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.
May 1, 2023
·
2 min read
·
Tristan Manalac
Kiora Pharmaceuticals Presents Encore Imaging Results of KIO-301 for Retinitis Pigmentosa at ASNR 2023 Meeting
Kiora Pharmaceuticals (NASDAQ: KPRX) announced today an encore presentation on KIO-301 neuroimaging results at The American Society of Neuroradiology 2023 Meeting in Chicago.
May 1, 2023
·
5 min read
BioMidwest
Genomic Urine Test Detects Bladder Cancer from DNA Up to 12 Years Before Clinical Signs and Symptoms Appear
A new genomic urine test can help doctors accurately predict bladder cancer as many as 12 years before clinical signs and symptoms emerge and long before a diagnosis can be made with cystoscopy, the most common method of detection, according to a new study* presented here at the 2023 American Urological Association (AUA) Annual Meeting.
May 1, 2023
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5 min read
Pharm Country
First Study to Evaluate JELMYTO® Use Post-Complete Endoscopic Ablation Reports 69% of Patients were Disease Free at the Time of First Endoscopic Evaluation
UroGen Pharma Ltd. (Nasdaq: URGN) today highlights the results of a sub-analysis from the first and largest post-commercial utilization review of JELMYTO (mitomycin) for pyelocalyceal solution presented today at the American Urological Association Meeting 2023 in Chicago, IL.
May 1, 2023
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11 min read
Pharm Country
SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-M™ Autologous SIRPαlow Activated Macrophage Immunotherapy
SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company’s lead product candidate, SIRPant-M™, an autologous SIRPαlow activated macrophage therapy for the treatment of aggressive tumors.
May 1, 2023
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3 min read
FDA
FDA Conditionally Approves First Drug for Anemia in Cats with Chronic Kidney Disease
The U.S. Food and Drug Administration conditionally approved Varenzin-CA1, the first drug for the control of nonregenerative anemia associated with chronic kidney disease in cats.
May 1, 2023
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4 min read
Business
MDxHealth to Present First Quarter 2023 Financial Results on May 15
MDxHealth SA, a commercial-stage precision diagnostics company, announced it will release its financial results for the first quarter ended March 31, 2023, after market close on Monday, May 15, 2023.
May 1, 2023
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1 min read
Business
CytomX Therapeutics to Report First Quarter 2023 Financial Results on May 9, 2023
CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced that it will report first quarter financial results on Tuesday, May 9, 2023, after the close of U.S. markets.
May 1, 2023
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2 min read
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