FDA warns Novo Nordisk over safety reporting violations
1. The FDA issued a warning letter to Novo Nordisk citing failures in required postmarketing adverse event reporting. 2. These ...
Tag: FDA
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2 Minute Medicine: Pharma Roundup – Pfizer’s Talzenna delays prostate cancer progression, apixaban lowers VTE bleeding risk, Lilly’s retatrutide hits Phase III metabolic targets, and FDA warns Novo Nordisk over safety reporting violations [March 2026]
Pfizer’s Talzenna combo significantly delays progression in frontline prostate cancer Topline results from the Phase 3 TALAPRO-3 study indicate that ...
FDA grants priority review for iberdomide-based myeloma regimen
1. The FDA has granted priority review for iberdomide, a first-in-class oral CELMoD designed to degrade transcription factors more effectively ...
![2MM: AI Roundup- AI Cancer Test, Smarter Hospitals, Faster Drug Discovery, and Mental Health Tech [May 2nd, 2025]](https://www.2minutemedicine.com/wp-content/uploads/2025/05/Untitled-design-350x250.png)
FDA clears Medtronic stealth AXiS AI-Robotic spine system
1. The Stealth AXiS™ system has received regulatory clearance as the first platform to natively unify AI-driven planning and robotic ...
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Yartemlea (narsoplimab-wuug) improves platelets hemolysis organ function hematopoietic stem cell transplant–associated thrombotic microangiopathy transplant patients
1. Yartemlea (narsoplimab-wuug) is the first on‑label complement inhibitor for hematopoietic stem cell transplant (HSCT) associated thrombotic microangiopathy, associated with improvements ...
FDA highlights flexible chemistry manufacturing controls expectations for cell and gene therapies
1. New FDA communication introduces a more flexible, risk‑based chemistry, manufacturing, and controls (CMC) framework for cell and gene therapies, ...
Nuzolvence (Zoliflodacin) first oral Gonorrhea treatment shows non-inferior cure rates
1. Nuzolvence (zoliflodacin) is the first single‑dose oral agent for uncomplicated urogenital gonorrhea, showing non‑inferior cure rates to ceftriaxone‑based therapy ...
2 Minute Medicine: Pharma Roundup – New oral gonorrhea antibiotic Nuzolvence (zoliflodacin), late‑December cardiovascular and oncology drug approvals, first targeted complement inhibitor therapy for HSCT‑TMA (Yartemlea), and antibody‑drug conjugate (ADC) safety concerns with ifinatamab deruxtecan (I‑DXd) [January 2026]
Oral gonorrhea antibiotic Nuzolvence approved just weeks ago The Food and Drug Administration recently approved Nuzolvence (zoliflodacin) as a first‑in‑class ...
2 Minute Medicine: Pharma Roundup – Breakthrough ALS gene therapy, new adult pneumonia vaccine, needle-free obesity treatment, and Pfizer’s business overhaul [October 28, 2025]
Amryta’s Sodesta gene therapy gains accelerated approval for ALS The Food and Drug Administration has granted accelerated approval to Sodesta, ...
Federal Drug Administration approves Alzheimer’s blood test for use in primary care
1. The FDA has cleared the first Alzheimer’s blood test for community use, marking a pivotal step toward earlier and ...
