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US FDA staff flags risk of low blood sugar for Novo Nordisk’s weekly insulin
WSAU Wausau· 4 days ago(Reuters) - The U.S. Food and Drug Administration's (FDA) staff on Wednesday pointed to "notable...
FDA advisory committee reviews Novo Nordisk insulin icodec for T1D
Pharmaceutical Technology via Yahoo Finance· 2 days agoThe US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee is...
The Biggest Publicly Traded Biotech Company
Insider Monkey via Yahoo Finance· 24 minutes agoIn this article, we will be discussing the biggest publicly traded biotech company that ranks at the top of our free list of the 20 Biggest Publicly...
Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review
Benzinga via Yahoo Finance· 3 days agoThe FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet on May 24 to...
Health Care: Republicans scrutinize FDA
Axios· 3 days agoThe FDA's drug approvals and oversight of lab-developed tests are again emerging as hot topics as House Republicans crank up oversight of the agency and...
Guardant wins FDA AdCom backing for colon cancer test
Medical Device Network via Yahoo Finance· 2 days agoDespite concerns over false negative results, the Medical Devices Advisory Committee (AdCom) for the...
FDA approves CorTec’s implant system for stroke rehabilitation study
Medical Device Network via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has granted approval for an investigational device...
FDA Advisors Not Convinced Once-Weekly Insulin Is Safe in Type 1 Diabetes
MedPage Today· 2 days agoAn FDA advisory committee mostly agreed on Friday that an investigational once-weekly insulin...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 5 days agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration ...
Mirat Shah, MD, on Elacestrant's FDA Approval for Breast Cancer With ESR1 Mutations
MedPage Today· 5 days agoFDA scientists published a detailed rationale for the approval of elacestrant (Orserdu), the first...