U.S. Food and Drug Administration
Regulatory agency
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View Timeline →Advancements in Psychedelic Treatments for Depression: Implications for Global Mental Health
Research into psychedelics as treatments for depression is advancing, with therapies like DT120 and COMP360 showing promise and receiving FDA breakthrough designations. This development could…
International Study Supports FDA Approval of HIV Drug for Newborns
An international study by the IMPAACT Network, including UC San Diego researchers, supported the FDA's approval of dolutegravir for treating HIV-1 in newborns. This approval…
Study Reveals Potential Conflicts of Interest Among FDA Patient Representatives
A study suggests that patient and consumer representatives on FDA panels may be influenced by pharmaceutical industry funding. This raises concerns about the integrity of…
FDA Approves New Immunotherapy for Rectal Cancer Patients, Potentially Reducing Need for Chemotherapy and Surgery
The FDA has approved the immunotherapy Jemperli for certain adults with untreated rectal cancer, potentially allowing them to avoid chemotherapy, radiation, and surgery. This development…
Study Reveals Incomplete Reporting of Medical Device Adverse Events Poses Safety Risks
A study published by The BMJ highlights that allowing medical device manufacturers to submit bulk reports of adverse events to the FDA can lead to…
Concerns Over Sterility in Pharmaceutical Manufacturing: Implications for Iran
The U.S. FDA recalled epinephrine injections due to sterility concerns, highlighting the risks of contamination in pharmaceutical manufacturing. This issue underscores the importance of stringent…
FDA Panel Supports Controversial Multi-Cancer Blood Test
A panel of U.S. FDA advisers has narrowly supported a blood test designed to detect over 50 types of cancer early, despite concerns about its…
FDA's Internal Disagreements Delay Approval of Tavneos for Autoimmune Diseases
The FDA faced internal disagreements regarding the approval of the drug Tavneos for rare autoimmune diseases, with experts cautioning against its approval. This situation highlights…
AACR's Annual Cancer Progress Report Highlights Advances in Cancer Research and Treatment
The AACR has published its 16th annual Cancer Progress Report, highlighting advancements in cancer research and treatment funded by U.S. federal agencies. While the report…
FDA Approves New Pill for Advanced Breast Cancer Guided by Blood Test
The FDA has approved a new daily pill for adults with advanced breast cancer, specifically for those whose tumors have evaded current treatments. This development…
FDA Approves New Treatment for Polycythemia Vera by Takeda Pharmaceuticals
The FDA has approved Takeda Pharmaceuticals' Mimrylo (rusfertide) for treating adults with polycythemia vera who have not responded to current therapies. This approval marks a…
FDA Approves Blood Test for Alzheimer's Disease Evaluation
The U.S. FDA has approved the PrecivityAD2 blood test for adults over 40 to assess cognitive impairment related to Alzheimer's disease. This development involves the…
Peptide Supplements: The Marketing Surge Outpacing Scientific Evidence
The article discusses the rise of peptide supplements, highlighting the gap between marketing and scientific validation. While peptides like insulin and GLP-1 are FDA-approved, many…
FDA Approves First Oral Treatment for Dermatomyositis in Adults
The U.S. FDA has approved Lisraya (brepocitinib) as the first oral treatment for dermatomyositis in adults. This approval is significant as it represents advancements in…
Study Examines Early Adoption of Liver Histotripsy Treatment in the U.S.
A study led by Dr. Allan Tsung at the University of Virginia examines the early adoption of the HistoSonics Edison histotripsy system for treating liver…
FDA Approves Innovative Treatment for Pancreatic Cancer
The U.S. FDA has approved a new treatment for pancreatic cancer, marking a significant advancement in cancer care. This development involves the U.S. healthcare system…
FDA Endorses Biomarker to Enhance Parkinson's Clinical Trials
The Critical Path Institute (C-Path) has received FDA support for a biomarker that could enhance clinical trials for Parkinson's disease. This development is part of…
Clear Eyes Eye Drops Recalled Nationwide Due to Sterility Concerns
Nearly 40,000 bottles of Clear Eyes eye drops are being recalled across the U.S. due to sterility concerns from the manufacturer. This recall could impact…
Trump Nominates Heidi Overton to Lead FDA Amid Controversial Health Policy Changes
Heidi Overton has been nominated by Trump to lead the FDA, aiming to implement significant changes in US health regulations. This nomination raises concerns about…
Results of Several Studies: 'Ozempic' Delays Biological Aging
Recent studies presented at a European conference indicate that the weight loss drug Ozempic (semaglutide) can significantly delay biological aging and improve various health conditions.…