Docket Number: FDA-2017-D-5868 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
TOPLINE: Fetuses exposed in utero to SARS-CoV-2 are not at an increased risk for neurodevelopmental problems in early childhood. METHODOLOGY: This prospective study aimed to assess […]
Background Nitrosamine drug substance-related impurities (NDSRIs) (a class of nitrosamines that are associated with or share structural similarity with the active pharmaceutical ingredient [API] of a […]
MADRID (Reuters) – The Madrid regional government on Thursday cancelled the traditional annual herding of flocks of sheep through the centre of the Spanish capital scheduled […]
(Reuters) – The Global Polio Eradication Initiative (GPEI) needs more funds and has pushed back by three years its target to officially wipe out all forms […]
Docket Number: FDA-2022-D-2061 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for holders of Type II active pharmaceutical ingredient […]
TOPLINE: Children with obesity and metabolic dysfunction–associated steatotic liver disease (MASLD) have a higher risk for youth-onset type 2 diabetes (T2D), and the risk increases dramatically […]
TOPLINE: VIENNA — Individuals with ulcerative colitis (UC) who carry the HLA-DRB1*01:03 allele are at increased risk of having a more severe disease course requiring major […]
BOSTON — Patients with chronic obstructive pulmonary disease (COPD) who have exacerbations requiring hospitalization should be monitored for cardiac arrythmias, investigators said. This recommendation is based […]
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