Browsing Tag
FDA
293 posts
Inozyme Pharma presents positive interim data on INZ-701 at CHOP Cardiology 2025
Inozyme Pharma Inc. (Nasdaq: INZY), a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases affecting bone…
GSK secures FDA approval for 5-in-1 meningococcal vaccine to expand protection for adolescents
GSK has received approval from the US Food and Drug Administration (FDA) for PENMENVY, a 5-in-1 meningococcal vaccine…
Kexing Biopharm secures FDA IND approval for GB05, advancing pediatric RSV treatment
Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) has received Investigational New Drug (IND) approval from the United States…
Bristol Myers Squibb’s Opdualag fails to meet primary endpoint in Phase 3 trial
Bristol Myers Squibb has announced that its Phase 3 RELATIVITY-098 clinical trial, designed to evaluate Opdualag (nivolumab and…
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…
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,…
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…
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…
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…
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…