A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
BLA for treatment in adults with ASCVD, very high or high risk of ASCVD including heterozygous familial hypercholesterolemia (FH) and adult and pediatric patients > 10 yrs with homozygous FH FDA ...
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has ac ...
INmune Bio (INMB) announced, following a Type C meeting with the U.S. Food and Drug Administration, FDA, its intent to submit a Biologics ...
PharmaTher Holdings (CSE:PHRM) is on track to resubmit information to the U.S. Food and Drug Administration (FDA) by the end ...
NanoViricides, Inc. (NYSE American:NNVC) (the 'Company') declared today that it is ready to fight the bird flu with its revolutionary ...
A biotechnology company in Research Triangle Park has taken a major step to develop a new option for patients in need of a ...
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Inc. announced that the FDA has extended the PDUFA goal date for its New Drug Application (NDA) for ET-400 to May 28, 2025, allowing the agency additional time to review supplemental information ...
KELO Sioux Falls on MSN8d
Bill to regulate vape products heads to House floorA bill that would seek to regulate vapor products in the state has passed through the House Health and Human Services ...
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