FDA approves Guardant’s blood test for colon cancer
The Food and Drug Administration (FDA) has recently approved Guardant Health’s Shield blood test, marking it as a primary screening tool for colorectal cancer for average-risk adults aged 45 and older. This approval positions the Shield test as a more appealing and convenient alternative to traditional colorectal cancer screening methods, such as colonoscopies and stool-based […]
FDA Grants Approval to Sun Pharma’s Alopecia Drug, Setting Stage for Competition with Eli Lilly and Pfizer
Alopecia areata, a condition characterized by sudden hair loss due to the immune system attacking hair follicles, affects both men and women and can involve areas of the body beyond the scalp. Estimates suggest that around 700,000 people in the U.S. suffer from this condition, with 300,000 experiencing what is considered severe alopecia areata. For […]
FDA’s Latest Guidance on Post-Approval Manufacturing Changes for Biosimilars Emphasizes Current Practices and New Dosage Forms: An Exclusive Analysis in Life Science
The FDA is enhancing its guidelines for biosimilar and interchangeable product applicants regarding post-approval manufacturing changes. The updated draft guidance focuses on new considerations for applicants looking to introduce new dosage forms or strengths, or to produce the product in facilities that also handle different versions of the biological product. This development is aimed at […]
FDA Issues Final Guidelines on Electronic Submissions for OTC Products | Exclusive Article in FDA Today
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Abbott Issues Recall for Freestyle Libre 3 Sensors Over Inaccurate Glucose Measurements
Abbott, a global healthcare company, recently announced a recal of a limited number of its Freestyle Libre 3 sensors in the United States, specifically those distributed in the first half of May. This action was taken after Abbott’s internal testing revealed that three specific lots of these continuous glucose monitor (CGM) sensors were potentially giving […]
EMA Committee Cites Safety Concerns in Negative Review of Eisai Alzheimer’s Drug
Eisai, a pharmaceutical company, has encountered significant challenges in introducing its Alzheimer’s drug, Leqembi, to the European market following a negative assessment by the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) advised against granting marketing authorization in Europe, citing that the drug’s benefits do not sufficiently outweigh its […]
Mid-Year Review: Novel Drug Approvals and Supporting Clinical Trials in 2024
In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products, revealing trends in the reliance on single pivotal trials and the racial/ethnic diversity of trial participants. This analysis by AgencyIQ offers a midpoint overview of drug approval processes and characteristics, including drugs’ indications, mechanisms, and […]
Mid-Year Review: Analyzing Newly Approved Drugs and Their Clinical Trials in 2024 | In-Depth Insights into Life Sciences
This text provides a brief insight into a report by AgencyIQ analyzing the drug approvals made by the FDA’s Center for Drug Evaluation and Research (CDER) in the first half of 2024. During this period, CDER approved 21 novel drug products. The analysis focuses on the number of these approvals that were based on a […]
Autobahn Therapeutics Prepares for Depression Drug Clinical Trials with $100M Funding
Over the years, there has been a growing awareness of the links between thyroid hormones and mood disorders, particularly depression. Autobahn Therapeutics, a pioneer in this field, is harnessing this relationship by developing a novel treatment aimed at enhancing the efficacy of depression medications when traditional antidepressants fall short. Autobahn’s breakthrough centers around the targeted […]
CDRH Director Shuren Steps Down Following 15-Year Tenure
Jeff Shuren, the longstanding director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), announced his decision to retire after a remarkable 15-year tenure. His departure is scheduled for later this year, with the transition of leadership beginning on July 28. Michelle Tarver, currently the deputy director for transformation at […]