FDA lists nationwide recall of over 11,000 bottles of blood pressure drug
The FDA announced a nationwide recall of 11,460 bottles of chlorthalidone 25 mg blood pressure tablets due to dissolution test failures.
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FDA
Medical Journal Retracts Paper on Amgen’s Tavneos Drug Trial After FDA Findings
The New England Journal of Medicine retracted a 2019 paper on Amgen’s Tavneos trial after FDA found data manipulation and proposed withdrawing approval.
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FDA Expands Pfizer’s Ibrance as Maintenance Therapy for HR-Positive, HER2-Positive Metastatic Breast Cancer
The FDA approved Pfizer’s Ibrance as maintenance therapy for HR-positive, HER2-positive metastatic breast cancer in combination with trastuzumab and endocrine therapy.
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FDA clears first gene-edited cell therapy for severe sickle cell disease, paving way for wider use of CRISPR-based treatments in US hospitals
The FDA approved CASGEVY™, the first CRISPR gene-edited cell therapy, for severe sickle cell disease patients 12 and older with recurrent crises.
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FDA Approves First Gene-Editing Therapy for Type 1 Diabetes, Marking Major Milestone in Cell-Based Treatment
As of mid-2026, the FDA has not approved any gene-editing therapies for type 1 diabetes, with such treatments still in preclinical stages.
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FDA approves first oral small‑molecule treatment RebiQuent for moderate to severe atopic dermatitis in adults
The FDA has not approved RebiQuent for moderate to severe atopic dermatitis; current oral treatments include abrocitinib and upadacitinib.
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FDA Warns Online Pharmacies Selling Counterfeit Semaglutide Weight-Loss Injections After Cluster of Severe Adverse Events
The FDA warns against counterfeit semaglutide injections sold online after severe adverse events linked to fake Ozempic products.
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Health-system and regulatory watchers brace for new FDA and HHS actions as mifepristone, vaccines, and psychedelic medicine dominate policy debate
Federal health officials prepare new FDA and HHS actions in 2024 amid debates on mifepristone, vaccines, and psychedelic medicine policies.
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FDA To Reconsider Rare Cancer Drug Ebvallo After Surprise Rejection
The FDA will reconsider Atara Biotherapeutics’ rare cancer drug Ebvallo after initially rejecting it due to manufacturing concerns.
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White House Orders Acceleration of Medical Treatments for Serious Mental Illness
President Trump signed an executive order to expedite FDA approval of psychedelic drugs for serious mental illness treatment in the U.S.
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