When submitting an ANDA, generic drug manufacturers need to submit one of the following four statements in accordance with the provisions of the Orange Book.

Atom Bioscience, a biotech company specializing in innovative therapies for inflammation and metabolic diseases, announced FDA approval for the Phase 1 trial of its new drug, ABP-745.

GLP-1R agonists are medications that regulate glucose metabolism and are used in the treatment of type 2 diabetes and obesity.

Ubix Therapeutics Granted Green Light from FDA for Initial Clinical Trial of Oral Drug UBX-303-1, a BTK Inhibitor Aimed at Treating Resistant B-Cell Cancers.

Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements.

NKGen Biotech, Inc. declares the commencement of treatment in its initial participant within a Phase 1/2a Study using its own SNK01, aimed for moderate Alzheimer's Disease.

STING agonists are drugs that activate the STING pathway, enhancing immune response against diseases like cancer.

NeuroBo Pharma has filed an Investigational New Drug request with the FDA, seeking approval to commence a Phase 1 trial on compound DA-1726 aimed at combating obesity.

It depends on what type of exclusivity is at issue.

Clover Biopharmaceuticals reports positive initial findings from a phase I trial evaluating SCB-219M, an advanced bispecific Fc-fusion TPO-RA protein developed with CHO cell systems, focusing on safety, efficacy, and pharmacokinetics.

Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes.

PPAR agonists are drugs that activate peroxisome proliferator-activated receptors, aiding in the treatment of metabolic disorders.