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December 10, 2021

Pandemic Mystery: Scientists Focus on COVID’s Animal Origins Pandemic Mystery: Scientists Focus on COVID’s Animal Origins

Nearly two years into the COVID-19 pandemic, the origin of the virus tormenting the world remains shrouded in mystery. Most scientists believe it emerged in the […]
December 10, 2021

Supreme Court Leaves Texas Abortion Law in Place Supreme Court Leaves Texas Abortion Law in Place

This is a breaking news story and will be updated with additional details and perspective as warranted. In a highly anticipated decision, the U.S. Supreme Court […]
December 10, 2021

Diabetes Tied to Parkinson’s Risk, More Rapid Disease Progression Diabetes Tied to Parkinson’s Risk, More Rapid Disease Progression

Diabetes mellitus (DM) is associated with Parkinson’s disease (PD) development, as well as more severe symptoms and more rapid disease progression, new research suggests. In a […]
December 10, 2021

Early Diagnosis of Bronchiectasis Critical in T2 Severe Asthma Early Diagnosis of Bronchiectasis Critical in T2 Severe Asthma

Type 2 inflammation likely has a causative role in the development of bronchiectasis (BE) in patients with type 2-high severe asthma (T2-SA), and its early diagnosis […]
December 10, 2021

‘Zombie’ Cells a New Treatment Target for Alzheimer’s? ‘Zombie’ Cells a New Treatment Target for Alzheimer’s?

Scientists have identified a potential new target for Alzheimer’s disease (AD) treatment. Investigators led by Miranda E. Orr, PhD, assistant professor of gerontology and geriatric medicine, […]
December 10, 2021

Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry

Submit Comments by 02/10/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
December 10, 2021

Glucarpidase Approval in Europe for Methotrexate Toxicity in View Glucarpidase Approval in Europe for Methotrexate Toxicity in View

Glucarpidase should soon be approved throughout Europe to treat methotrexate toxicity. The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recently recommended the […]
December 10, 2021

Experts Debate Aspirin for Primary Prevention in Type 2 Diabetes Experts Debate Aspirin for Primary Prevention in Type 2 Diabetes

“Aspirin should be reserved for secondary prevention in type 2 diabetes” was the title of a debate at the International Diabetes Federation’s 2021 virtual meeting. The […]
December 10, 2021

Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry

Docket Number: FDA-2020-D-1301 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations for permitted […]
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