Food and Drug Administration (FDA)

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UCB has announced that it is acquiring Zogenix as part of plans to expand its reach into commercializing and developing treatments for rare diseases.
The new pancreatic cancer vaccine from ImmunityBio shows very promising results. Here’s what you need to know about the vaccine and its result from the tests.
Moderna is poised to commercialize its COVID-19 and influenza combination vaccine by the fall of 2023, with some potential for the same drug to also be viable against the RSV.
The agency recommended another clinical trial be conducted to confirm the data from the study on the 3.2-mg dose of the intranasal carbetocin for Prader-Willi syndrome.
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.
The approval of Cibinqo was based on data from five clinical trials of more than 1,600 people. Safety and efficacy were studied in three Phase III trials.
Martin Shkreli and his former company, Vyera Pharmaceuticals, earned a 5,000% increase on the toxoplasmosis drug, Daraprim.
Former Food and Drug Commissioner Robert Califf is one step closer to returning to his old office after the Senate Health, Education, Labor and Pensions Committee advanced his nomination.
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