Early Phase I results for JNJ-79635322 demonstrated an 86.1% overall response rate in heavily pretreated multiple myeloma ...

The FDA grants fast track designation to PHST001, an antibody targeting CD24, for advanced platinum-resistant and ...

MRK wins early FDA approval for RSV antibody Enflonsia in infants, with U.S. launch planned before the 2025-26 season.

PDUFA date of June 13th 2025 by which FDA will decide upon whether or not UGN-102 should be approved for patients with ...

The Food and Drug Administration (FDA) has approved Enflonsia ™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who ...

New members of the Advisory Committee on Immunization Practices have not yet been identified, but they are expected to meet later this month. Separately, the FDA has approved Merck's monoclonal ...

Merck’s Enflonsia will go up against Sanofi and AstraZeneca’s Beyfortus, which the partners plan to ship out early in the ...

The approval was based on data from the pivotal Phase IIb/III CLEVER trial which assessed a single dose of the antibody.

The U.S. Food and Drug Administration on Monday approved Merck's preventive antibody shot to protect infants up to one year ...

An autoantibody associated with systemic lupus erythematosus may help improve the performance of immune checkpoint inhibitor ...

Clesrovimab joins the monoclonal antibody nirsevimab (Beyfortus), as well as the maternal bivalent RSV prefusion F protein ...

Meanwhile, Sanofi has pointed to Beyfortus’ 75% reduction in the incidence of MALRI versus Enflosia’s figure of 60%. The ...