Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk
The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk
The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk
The researchers removed a chemical group commonly used in previous NK1R drugs and replaced it with a novel molecular scaffold
The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination therapy
The FDA also noted that current prescribing information for GLP-1 RAs already includes warnings about the risk of suicidal thoughts
BioNTech is positioning 2026 as a defining year in its transition toward a multi-product oncology company
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function
MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms
Vanda strongly disputes the FDA’s reasoning
The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue
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