Food and Drug Administration (FDA)
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Sprout wanted the warning regarding alcohol to be completely removed but the FDA said it must remain, although with a caveat.
There’s little doubt that Merck’s checkpoint inhibitor Keytruda (pembrolizumab) is about as close to a miracle drug as we get.
Ultragenyx Pharmaceutical Inc. announced that management and external experts will provide an update to the investment community on the global commercial launch of Crysvita®, the company’s gene therapy programs and platform including manufacturing capabilities, and preclinical data on the next three Investigational New Drug applications the company plans to submit to the U.S. Food and Drug Administration.
Since taking over the role of chief executive officer at Bothell, Wash.-based Alder BioPharmaceuticals in June 2018, Robert Azelby has maintained his focus on moving the company closer to launching its first commercial product in the migraine treatment space.
The agency approved Evenity on the basis of two Phase III clinical trials. The drug had been rejected in 2017 over safety concerns.
PhaseBio Pharmaceuticals, based in Malvern, Penn. and San Diego, announced that its antiplatelet drug PB2452 had received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
Zogenix said the FDA determined that the NDA, which was submitted in February, was not “sufficiently complete to permit a substantive review.”
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for HIV-1 in adults who had not received treatment before.
Celgene and its developmental partner Acceleron Pharma are eying a potential U.S. Food and Drug Administration approval of a blood-disease treatment.
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