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Merck and Ridgeback Biotherapeutics have become the first companies to file an application seeking Emergency Use Authorization (EUA) for an oral antiviral that treats COVID-19 — which could transform treatment of infections with the deadly virus. Read More
Rethymic, a cultured human thymus tissue developed by Enzyvant, has won FDA approval as the first-ever thymus tissue transplant product approved in the U.S. Read More
ChemoCentryx has secured FDA approval for oral Tavenos (avacopan) as an adjunctive therapy for adults with a potentially fatal autoimmune disease characterized by over-activation of the complement system. Read More
The long-acting combination could offer protection for those unable to mount a proper immune response after receiving a COVID-19 vaccine, the company said. Read More
AstraZeneca has filed for an FDA Emergency Use Authorization (EUA) for its long-acting antibody (LAAB) combination, AZD7442, as a preventive for symptomatic COVID-19. Read More
Johnson & Johnson (J&J) submitted its application yesterday to the FDA for emergency authorization of a booster dose of its COVID-19 vaccine in adults 18 years and older. Read More
Gilead Sciences’ anti-CD19 CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), has gained a second indication as the first-ever CAR T therapy for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Read More