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.
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.”
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.
Sineugene Therapeutics Co. Ltd. has obtained IND clearance from the FDA for SNUG-01, a first-in-class tripartite motif protein 72 (TRIM72)-targeted gene therapy candidate for amyotrophic lateral sclerosis (ALS). A phase I/IIa trial will evaluate SNUG-01 in adults with ALS.
The U.S. Medicare program took several bites out of rates paid for radiation oncology services under the physician fee schedule, but stakeholders are again gaining traction on Capitol Hill with a plea for intervention.
Everest Medicines Ltd. has obtained IND clearance from the FDA for EVM-14, an off-the-shelf mRNA cancer vaccine targeting multiple tumor-associated antigens and designed to treat various cancers, including non-small-cell lung cancer and head and neck cancer.
Entrada Therapeutics Inc. has received authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and research ethics committee to initiate a phase I/II study of ENTR-601-45 for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 45 skipping.
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.
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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