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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
161 Results
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BioMidwest
Xeris Ships One Millionth Gvoke® Unit
Xeris Biopharma Holdings, Inc. announced that Xeris has shipped more than one million units of Gvoke® – the company’s ready-to-use liquid glucagon for the treatment of severe hypoglycemia in adults and children with diabetes ages 2 years and above.
July 31, 2023
·
7 min read
Freeline to Participate in Upcoming Investor Conferences - July 31, 2023
Freeline Therapeutics Holdings plc announced that the company will be participating in two upcoming investor conferences in August.
July 31, 2023
·
1 min read
Drug Development
BridgeBio Pharma Announces Opportunity for Accelerated Approval Pathway in Limb-girdle Muscular Dystrophy Type 2I (LGMD2I/R9) Based on Glycosylated Alpha-dystroglycan (⍺DG) Levels and Announces First Patient Dosed in FORTIFY Phase 3 Study
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”) today announced that, based on discussions with the U.S. Food and Drug Administration (FDA), there is a potential path to pursue accelerated approval in the U.S. for BBP-418, an investigational oral substrate supplementation therapy, in patients with limb-girdle muscular dystrophy type 2I (LGMD2I/R9).
July 31, 2023
·
10 min read
Business
Appendix 4C – Q4 FY23 Quarterly Cash Flow Report
Alterity Therapeutics Limited, a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 June 2023.
July 31, 2023
·
7 min read
Business
iCAD to Report Second Quarter 2023 Financial Results on August 14, 2023
iCAD, Inc today announced it will release financial results for the second quarter of 2023 and host a conference call at 4:30 PM ET on Monday, August 14, 2023.
July 31, 2023
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2 min read
Drug Development
Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra™ In Patients With Sepsis
Enlivex Therapeutics Ltd. today announced that the first patient has been dosed under the amended protocol for the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis.
July 31, 2023
·
4 min read
FDA
FDA Authorizes Marketing of MAGENTIQ-COLO™, a Cutting-Edge AI Gastrointestinal Lesion Software Detection System that Helps Detect Lesions in Real Time During Colonoscopy Procedures
MAGENTIQ-EYE LTD., an Israeli-based technology company founded in 2014, announced today that the U.S. Food and Drug Administration (FDA) has cleared the MAGENTIQ-COLO™ via the 510(k) process.
July 31, 2023
·
3 min read
Lone Star Bio
Fuzionaire Diagnostics, Inc. Announces Name Change to Fuzionaire Theranostics, Inc. and Preclinical Oncology Pipeline
Fuzionaire Diagnostics, Inc. announced today that it has changed its name to Fuzionaire Theranostics, Inc. (“Fuzionaire Tx”).
July 31, 2023
·
4 min read
Genetown
Quanterix’s Simoa® Technology Powers Large, International Reference Range Study Utilizing Serum Neurofilament Light (sNfL) to Assess Neurological Disease Activity in Pediatric Patients
Quanterix’s Simoa ® Technology Powers Large, International Reference Range Study Utilizing Serum Neurofilament Light (sNfL) to Assess Neurological Disease Activity in Pediatric Patients.
July 31, 2023
·
7 min read
Pharm Country
Melinta Therapeutics Announces Commercial Availability of REZZAYO™ (rezafungin for injection)
Melinta Therapeutics, LLC today announced the availability of REZZAYO™ (rezafungin for injection), for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.
July 31, 2023
·
4 min read
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