Federal Register notice: FDA makes available a draft guidance entitled QTc Information in Human Prescription Drug and Biological Product Labeling.
Aspen says it will start a Phase 1/2a trial of its ANPD001 cell therapy to treat Parkinsons disease under an FDA-approved IND.
FDA accepts for review a Vitaris/Mapi ANDA for GA Depot 40 mg as a once-monthly injection to treat relapsing multiple sclerosis.
A Health Affairs article calls on doctors and health systems to take steps to test generic drugs to minimize risks to patients.
A Congressional Research Service report says a 2021 law codified FDAs approach to defining a new chemical entity in regulations including exclusivity....
Five drug companies agree to pay $42 million to settle a Texas enforcement action involving allegedly improper reimbursements for certain pharmaceutic...
FDA grants HuidaGene Therapeutics a rare pediatric disease designation for HG004 and its use in treating inherited retinal disease caused by RPE65 mut...
FDA grants traditional approval for Genentechs Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged during transfection) ...
