Regeneron Pharmaceuticals, Inc. announced that the FDA has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy.
Dynavax Technologies Corporation has announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for Heplisav B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Dynavax Technologies reported preliminary top-line results from HBV-23, a Phase III trial of the safety and immunogenicity of its investigational...
Dynavax Technologies Corporation announced that the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that...
Ionis Pharmaceuticals announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase III studies evaluating the safety and efficacy of GSK 3228836 (bepirovirsen) (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection (CHB)
Dynavax Technologies Corporation announced that the FDA has accepted for review the Biologics License Application (BLA) for Hepilisav-B, the company's...
Dynavax Technologies Corporation (DVAX) announced today that the FDA has informed the company that the Vaccines and Related Biological Products...
Thymic cell populations from 12 patients displaying myasthenia gravis were submitted to a phenotypic and functional study.