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Keytruda/Padcev Study in Bladder Cancer Positive: Merck

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Merck announces that the combination of Keytruda (pembrolizumab) and Pfizers Padcev (enfortumab vedotin-ejfv), given before and af...

Get Strategic Intelligence from Device Warnings

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A MedDevice Online column says manufacturers can often avoid an FDA Warning Letter by providing an urgent and accountable full res...

FDA May Nix Pfizer EUA for Covid Jab in Young Kids

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The Guardian reports that the emergency use authorization for Pfizers Covid-19 vaccine for children under five may not be renewed ...

Hes Back: Makary Rehires Prasad as CBER Head

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Vinay Prasad returns as CBER head at FDA commissioner Marty Makarys request after gaining White House approval.

Novartis to Seek Approval for Sjgrens Disease Drug

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Novartis says that it will seek FDA approval of its investigational drug ianalumab after it met the primary endpoint in two Phase ...

GSK sNDA for Oral Gonorrhoea Treatmemt

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FDA accepts for priority review a GSK supplemental NDA for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoe...

IO Biotechs Cancer Vaccine Misses Trial Significance

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IO Biotech says its investigational cancer vaccine Cylembio (imsapepimut and etimupepimut, adjuvanted), combined with Mercks Keytr...

Nyxoahs Genio Device OKd for Sleep Apnea

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FDA approves Nyxoahs Genio system, a hypoglossal nerve stimulation therapy for certain patients with moderate to severe obstructiv...

FDA Hits Dr. Reddys Plant with 7-Item 483

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FDA investigators cite seven GMP deficiencies from an inspection conducted last month at a Dr. Reddys drug manufacturing plant in ...