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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
Pfizer declined to comment on the precise timing of its submission to the FDA and said it can’t “speculate on how long the FDA’s review will take.” Read More
Tivdak must carry a boxed warning for ocular toxicity, as well as warnings for peripheral neuropathy, hemorrhage, pneumonitis and embryo-fetal toxicity. Read More
The FDA has approved Byooviz (ranibizumab-nuna), the first biosimilar to Roche’s blockbuster Lucentis (ranibizumab) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for older Americans. Read More