The FDA has scuttled Merus’ plans to win a speedy approval for i | The FDA has scuttled Merus’ plans to win a speedy approval ...
The U.S. Food and Drug Administration on Tuesday extended the review of Merus NV's gene-targeting cancer therapy to allow ...
SimBioSys announced that it received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons ...
FDA is giving the food and beverage industry an additional two months to respond to its request that they slash sodium in ...
The FDA faces policy challenges as technological advances roil health care and the agency fights for resources from Congress — no matter who wins the election.
A range of bread products has been recalled and classified by the U.S. Food and Drug Administration (FDA) because of the presence of an unlabeled allergen. Aunt Millie's Bakehouse products produced by ...
The FDA has extended its review of zenocutuzumab's in NRG1+ NSCLC and PDAC to February 2025, with efficacy and safety data ...
The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the treatment of atopic dermatitis in adults and ...
Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika ...
The U.S. Food and Drug Administration (FDA) has issued a recall for Dynacare baby powder, which was sold in 35 states, due to ...
The FDA continues to approve new drugs and expand indications for others at a rapid pace. Here’s a summary of what happened ...
Journey Medical said on Monday the U.S. Food and Drug Administration has approved its drug for the treatment of a long-term ...