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Recent items include:
- <![CDATA[What Moments in FDA’s Review Process Should Patients and Providers be Watching Closely?]]>
- <![CDATA[Your Questions Answered: Two FDA Approvals, Six Platform Deals, and a European Warning]]>
- FDA issues red alert for US heart pump system
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<![CDATA[Your Questions Answered: Two FDA Approvals, Six Platform Deals, and a European Warning]]>
MedWatch: Τι αποκαλύπτουν 13.712 «ύποπτα» ευρήματα για δομές Υγείας
Το «ψηφιακό ραντάρ» σαρώνει το Διαδίκτυο εντοπίζοντας πρακτικές που μπαίνουν στο μικροσκόπιο των ελεγκτικών αρχών – Τι δείχνουν τα νεότερα στοιχεία σε Αθήνα, Πειραιά και Θεσσαλονίκ...
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Onswik]]>
FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies
By Sarah Wicks & Deborah L. Livornese & Michelle L. Butler —
The paperwork problem: How many FDA warning letters actually cite document failures
When people take a medication, they trust that it contains the right amount of active ingredient and is free of harmful contamination. Manufacturing and test records help verify th...
Health Ministry approves biovigilance programme to monitor adverse drug reactions
The programme will focus on reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplant
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Fayuvi]]>
FDA warns three importers about missing foreign supplier documents
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...
Nutromics Nabs FDA Breakthrough Status for Antibiotic Monitoring Patch
Nutromics earned FDA breakthrough device designation for its wearable patch that tracks vancomycin levels in real time. The device aims to replace the periodic blood draws currentl...
Supplements dominate cross-border alerts in Europe
Twenty alerts mentioned the United States
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Zanvastro]]>
<![CDATA[FDA Approves Lisraya for Adults with Dermatomyositis, Bixlenvo for Virologically Suppressed Adults with HIV,...
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Welireg Plus Lenvima]]>
GLP-1 Telehealth Ads: What Regulators Flagged in 2026
GLP-1 telehealth ads regulators flagged: generic, same active ingredient and clinically proven claims for compounded drugs, plus a compliance table.
FDA warns three Northeast food importers about missing supplier verification programs
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...
FDA report shows investigative teams reviewed 69 incidents in 2025
The Food and Drug Administration has just published its 2025 report on the activities of the Coordinated Outbreak Response, Evaluation, & Emergency Preparedness teams.The FDA’s...
FDA adds boxed warning to Injectafer for hypophosphatemia risk
The FDA added a boxed warning detailing the known risk for symptomatic hypophosphatemia associated with ferric carboxymaltose injection, according to an agency press release.The bo...
<![CDATA[Pharmaceutical Executive Daily: FDA Grants Accelerated Approval to Jemperli]]>
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Hibsago]]>
FDA and SEC Enter MOU to Establish Information Sharing Framework
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