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Photomicrograph of bone marrow aspirate showing myeloblasts of acute myeloid leukemia
Cancer

Pleco holds pre-IND meeting with FDA on PTX-252 for AML

March 26, 2025
Pleco Therapeutics BV has held a successful pre-IND meeting with the FDA to discuss the continued development of PTX-252, an intravenous formulation designed to treat patients with acute myeloid leukemia (AML).
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Tape measure wrapped around scale
Endocrine/metabolic

PL-7737 gets orphan drug status for leptin receptor deficiency

March 26, 2025
Palatin Technologies Inc. has obtained U.S. orphan drug designation for PL-7737 for leptin receptor (LEPR) deficiency, including obesity caused by this condition.
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FDA clears new class of antibiotic with nod for GSK’s Blujepa

March 25, 2025
By Jennifer Boggs
Ushering in a new class of antibiotics, the U.S. FDA approved GSK plc’s gepotidacin for use in uncomplicated urinary tract infections. Branded Blujepa, the oral triazaacenaphthylene bacterial topoisomerase inhibitor is indicated for treating female adults and adolescents, 12 and older.
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US FDA deals second blow to Hengrui-HLB’s liver cancer drug combo

March 25, 2025
By Marian (YoonJee) Chu
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
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Green approved stamp
Biopharma regulatory actions and approvals February 2025

Global drug approvals hit 47 in February, surpassing 2024 monthly average

March 25, 2025
By Amanda Lanier
The U.S. FDA approved 16 drugs in February, up from 12 in January but still falling short of the 2024 monthly average of 19 approvals. Just two of those were new molecular entities (NMEs), continuing a slower pace compared to the year’s average of slightly more than four NMEs per month.
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3D illustration of mesenchymal stem cells

Nature Cell wins FDA breakthrough designation of Jointstem

March 25, 2025
By Marian (YoonJee) Chu
Nature Cell Co. Ltd. won U.S. FDA breakthrough therapy designation of its autologous adipose-derived mesenchymal stem cell therapy, Jointstem, March 20, becoming the first Korean company to earn the label in the field of cell therapy.
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PhRMA takes aim at most of world for unfair trade practices

March 25, 2025
By Tamra Sami
In a move that echoes tariff threats from U.S. President Donald Trump, the Pharmaceutical Research and Manufacturers of America (PhRMA) lobby is taking aim at most of the world for unfair trade practices in its special 2025 Special 301 Report to the U.S. Trade Representative.
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Art concept for antimicrobial research

FDA clears Biomérieux’s Vitek Compact antimicrobial resistance system

March 25, 2025
By Shani Alexander
Biomérieux SA recently received U.S. FDA 510(k) clearance for its Vitek Compact Pro, a system for microorganism identification and Antibiotic Susceptibility Testing. The company hopes that the system will help clinical laboratories combat antimicrobial resistance and diagnose infectious diseases as well as support industrial laboratories in identifying contaminants to ensure consumer safety.
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Product recall concept image

Smith’s Medical removes endotracheal tubes due to small diameter

March 25, 2025
By Mark McCarty
The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
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FDA approved icons and medical professional

Have kit, will travel further: Telix PET-imaging agent approved by FDA

March 25, 2025
By Lee Landenberger
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
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