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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
Mirum also received a rare pediatric disease priority review voucher for the treatment, which it can either use for a future application or sell to another drug sponsor. Read More
An FDA vaccines advisory committee will meet Oct. 14-15 to consider whether to recommend booster doses of Moderna’s and Johnson & Johnson’s (J&J) COVID-19 vaccines for adults 18 years and older, including assessing whether to support a mix-and-match approach using different jabs. Read More
Merck and Ridgeback Biotherapeutics have pulled ahead in the race to get the first Emergency Use Authorization (EUA) for an oral antiviral for COVID-19. They’re expected to file for approval this month. Read More