A decision from the FDA is due by 28 September.
Sanofi’s multiple sclerosis candidate tolebrutinib is in line for a potential US approval in the autumn after the Food and Drug Administration agreed to a speedy review of the oral Bruton’s tyrosine kinase (BTK) inhibitor.
The regulatory agency is evaluating tolebrutinib under priority review for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and...
The first Phase III data for the CD38-targeting antibody is expected in 2027 in antibody-mediated rejection in kidney transplant patients, followed by other indications.
The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.
Series B cash will be used to advance its Stargardt disease gene therapy.
PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.
Series B cash will be used to advance its Stargardt disease gene therapy.
PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.
Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.
