Can Thykamine change the future of MASH treatment? Devonian Health Group says yes!
Devonian Health Group Inc. (TSXV: GSD; OTCQB: DVHGF), a clinical-stage pharmaceutical company, has announced promising preclinical results for its proprietary drug candidate, Thykamine, in MASH ... Read More
Moleculin Biotech moves forward with pivotal Annamycin trial in AML after FDA backing
Moleculin Biotech, Inc. (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing innovative treatments for acute myeloid leukemia, has received critical guidance from the U.S. ... Read More
Pfizer’s ADCETRIS combination regimen secures FDA approval for relapsed large B-cell lymphoma
The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc.’s supplemental Biologics License Application (sBLA) for ADCETRIS (brentuximab vedotin) in combination with lenalidomide and ... Read More
FDA approves Genentech’s Evrysdi tablet as first SMA treatment in tablet form
In a significant development for the treatment of spinal muscular atrophy (SMA), the U.S. Food and Drug Administration (FDA) has approved Genentech’s Evrysdi tablet, marking ... Read More
Roche’s Gazyva shows superior efficacy in lupus nephritis treatment, Phase III trial data reveals
Roche has announced promising new data from its phase III REGENCY clinical trial, published in the New England Journal of Medicine, highlighting the superior efficacy ... Read More
FDA grants breakthrough device designation to Acrivon’s OncoSignature assay for endometrial cancer
Acrivon Therapeutics has secured a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its OncoSignature assay approval, a biomarker-driven diagnostic test ... Read More
Supernus wins FDA approval for ONAPGO, a continuous infusion therapy for Parkinson’s disease
The U.S. Food and Drug Administration (FDA) has granted approval to Supernus Pharmaceuticals, Inc. for ONAPGO (apomorphine hydrochloride) injection, marking a milestone in Parkinson’s disease ... Read More
Roche secures FDA approval for HER2-ultralow metastatic breast cancer diagnostic
Roche has received FDA approval for an expanded use of its PATHWAY HER2 (4B5) test, marking a significant breakthrough in breast cancer diagnostics. This development ... Read More
Wockhardt’s Zaynich achieves record-breaking 96.8% clinical cure rate in cUTI Phase III trial
Wockhardt Limited has announced a major breakthrough in the treatment of complicated urinary tract infections (cUTI) with its novel antibiotic Zaynich (Zidebactam/Cefepime, WCK 5222). In ... Read More
FDA approves Leqembi maintenance dosing for early Alzheimer’s treatment
The U.S. Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi (lecanemab-irmb), an innovative treatment for early Alzheimer’s disease developed ... Read More