The FDA's CRL to Merck (MRK) and its partner Daiichi Sankyo for the patritumab deruxtecan BLA is based on observations made on inspection of a...
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BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (TSE...
The FDA's CRL to Merck (MRK) and its partner Daiichi Sankyo for the patritumab deruxtecan BLA is based on observations made on inspection of a...
NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food...
AbbVie (ABBV) issues the second CRL for Parkinson's disease medicine, ABBV-951, based on some observations on inspection of one of its third-party...
IceCure Medical's (ICCM) XSense Cryoablation System receives FDA approval, marking a pivotal step in minimally-invasive tumor treatment across...
On June 21, 2024, the FDA converted Sirturo (bedaquiline) from accelerated approval to traditional approval following a determination that a...
Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte...
On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager,...
PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration...