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CDC Set To Make Monkeypox A Nationally Notifiable Condition; New Designation Will Take Effect Aug. 1

By Benzinga Newsdesk
July 27, 1:32 PM
-Politico Report

AEMD

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  • FDA
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GSK Announces U.S. FDA Approval of Benlysta (Belimumab) For Pediatric Patients With Active Lupus Nephritis

By Benzinga Newsdesk
July 27, 1:20 PM
GSK plc (NYSE:GSK) today announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving

GSK

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  • FDA
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Bavarian Nordic Is Now Allowed To Deliver Jynneos/Imvanex Smallpox And Monkeypox Vaccine Manufactured At Its Own Site To U.S. And EU Market

By Benzinga Newsdesk
July 27, 10:23 AM
-Reuters

AEMD

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  • Biotech
  • FDA
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Medicenna Announces New Clinical Data Providing Preliminary Evidence Of MDNA11’s Single Agent Anti-Cancer Activity In The Phase 1/2 ABILITY Study

By Benzinga Newsdesk
July 27, 8:16 AM
-- Tumor control was achieved in four of ten evaluable patients with advanced solid tumors unresponsive to other treatments enrolled in the ABILITY Study’s low and mid-stage dose escalation cohorts --

MDNA

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  • Biotech
  • FDA
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Mustang Bio Announces First Patient Successfully Treated By Ex Vivo Lentiviral Gene Therapy To Treat RAG1 Severe Combined Immunodeficiency

By Benzinga Newsdesk
July 27, 8:14 AM
Mustang Bio, Inc. (“Mustang”) (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for

MBIO

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  • Biotech
  • FDA
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Soligenix Receives Agreement From FDA On Initial Pediatric Study Plan For HyBryte For The Treatment Of Cutaneous T-Cell Lymphoma

By Bill Haddad
July 27, 7:35 AM
Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced

SNGX

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  • FDA
  • News

Prometheus Biosciences Plans To File Investigational New Drug Application For PRA052 In Q3 2022

By Benzinga Newsdesk
July 26, 4:26 PM
-SEC Filing

RXDX

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  • Biotech
  • FDA
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Oramed Reaches 50% Enrollment In Its Second Phase 3 Oral Insulin Trial

By Benzinga Newsdesk
July 26, 7:55 AM
-  ORA-D-013-2 is the second of two Phase 3 trials under FDA protocol -  ORA-D-013-1, the larger of the two trials, completed enrollment with top line data expected January 2023

ORMP

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  • Biotech
  • FDA
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Diffusion Pharmaceuticals To Initiate Phase 2 Trial In Patients With Glioblastoma Multiforme Incorporating Innovative Imaging Methodology To Evaluate Tumor Oxygenation

By Benzinga Newsdesk
July 26, 7:37 AM
Diffusion aligns with FDA on design of an open-label, dose-escalation, Phase 2 safety and efficacy study of trans sodium crocetinate (“TSC”) in newly diagnosed glioblastoma multiforme (“GBM”)

DFFN

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2 minute read
  • Biotech
  • FDA
  • General
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Bausch + Lomb Enrolls First Patient In LASIK Clinical Trial Evaluating Use Of Technolas TENEO™ Excimer Laser For Vision Correction Surgery for Hyperopia with Astigmatism

By Benzinga Newsdesk
July 26, 6:59 AM
Bausch + Lomb Corporation (TSX:BLCO) ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, today announced that the company has enrolled the first patient

BLCO

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