https://www.medtechdive.com/news/device-to-preserve-donor-lungs-wins-fda-approval/553721/
Device to preserve donor lungs wins FDA approval | MedTech Dive
The system could expand availability of donor lungs by preserving the organ for up to five hours, giving the transplant team time to reassess marginal lungs...
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https://www.biopharmadive.com/news/ferring-fda-approval-bladder-cancer-gene-therapy/639078/
Ferring wins FDA approval for bladder cancer gene therapy | BioPharma Dive
The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the...
wins fda approvalbladder cancergene therapyferringbiopharma
https://www.medtechdive.com/news/abbott-heart-device-for-premature-babies-wins-fda-approval/546051/
Abbott heart device for premature babies wins FDA approval | MedTech Dive
The device for sealing a hole in the heart of premature infants is smaller than a pea and can treat newborns weighing as little as 2 pounds.
wins fda approvalpremature babiesabbottheartdevice
https://www.biopharmadive.com/news/gsks-5-in-1-meningococcal-shot-wins-fda-approval/740144/
GSK’s 5-in-1 meningococcal shot wins FDA approval | BioPharma Dive
Feb 18, 2025 - Penmenvy, which protects against five common types of disease-causing bacteria, is cleared for use in people aged 10 through 25 years old.
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https://www.biopharmadive.com/news/pfizer-fda-approval-meningococcal-vaccine-penbraya/697441/
Pfizer wins FDA approval of new meningococcal vaccine | BioPharma Dive
The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.
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https://www.biopharmadive.com/news/ascendis-fda-approval-yuviwel-achondroplasia-biomarin-voxzogo/813502/
Ascendis wins FDA approval of dwarfism drug | BioPharma Dive
Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo.
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https://www.medtechdive.com/news/cardiva-wins-fda-approval-for-its-vascular-closure-system/544733/
Cardiva wins FDA approval for its vascular closure system | MedTech Dive
The Santa Clara, California-based company succeeded in its PMA application and can now market the Vascade MVP device for use in electrophysiology procedures.
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https://www.medtechdive.com/news/saturated-oxygen-treatment-for-heart-attack-wins-fda-approval/552095/
Saturated oxygen treatment for heart attack wins FDA approval | MedTech Dive
The catheter-based device from Irvine, California-based TherOx aims to reduce muscle damage by delivering hyperbaric levels of oxygen to heart tissue.
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https://www.biopharmadive.com/news/moderna-rsv-vaccine-fda-approval/715544/
Moderna wins FDA approval for RSV vaccine | BioPharma Dive
The OK for mResvia adds another option for preventing RSV-related disease in older adults, one year after the agency cleared shots from GSK and Pfizer.
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https://www.medtechdive.com/news/guardant-fda-approval-Shield-colon-cancer-blood-test/722665/
Guardant wins FDA approval for colon cancer blood test | MedTech Dive
Colorectal cancer screening rates could increase if the Shield test appeals to people who have avoided colonoscopies or stool-based tests, the company said.
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https://www.medtechdive.com/news/Johnson-JJ-FDA-approval-Varipulse-PFA/732277/
J&J wins FDA approval for Varipulse PFA system | MedTech Dive
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https://www.biopharmadive.com/news/pfizer-rsv-vaccine-fda-approval-abrysvo/651630/
Pfizer’s RSV vaccine wins FDA approval in older adults | BioPharma Dive
The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.
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