The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.

South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.

Reflecting the evolving scientific understanding of Alzheimer’s disease, the U.S. FDA revised its 2018 draft guidance on developing drugs to treat early Alzheimer’s.

South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.

It has been previously demonstrated that TREM2 is extensively shed during chronic neuroinflammation, which hiders its function, while TREM2 activation enhances effector functions of microglia.

Tumors in the stomach and pancreas are known to express claudin 18.2 (CLDN18.2) and the absence of expression in normal tissues makes it an attractive therapeutic target.

T-cell-engaging antibodies (TCEs) are synthetic molecules that redirect T cells to bind to the antigens on the surface of cancer cells to promote tumor elimination. In the case of multiple myeloma (MM), the approvals of anti-CD38 monoclonal antibodies (MAbs), chimeric antigen receptor T-cell therapies (CAR T) targeting B-cell maturation antigen (BCMA) or, more recently, bispecific TCEs represent great advances, but some patients still relapse after treatment.