The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
The U.S. Food and Drug Administration granted vTv Therapeutics’ TTP399 Breakthrough Therapy designation for type 1 diabetes.
The pause of Johnson & Johnson’s Covid-19 vaccine will not slow U.S. vaccination efforts, the White House COVID-19 coordinator said on April 13, adding that officials were working to reschedule people with other shots made by Pfizer and Moderna.
The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.
U.S. federal health agencies on April 13 recommended pausing the use of Johnson & Johnson’s Covid-19 vaccine after six women under 50 given the shot developed rare blood clots, dealing a fresh setback to efforts to tackle the pandemic.
Pfizer Inc. and the company’s German partner BioNTech SE on April 9 asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15 years old.
Shares of FibroGen were down after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug roxadustat.
The U.S. Food and Drug Administration granted full approval to Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Pfizer Inc. said on April 7 the U.S. Food and Drug Administration extended the review of the company’s experimental atopic dermatitis drug by three months, the latest regulatory setback for a class of treatments known as JAK inhibitors.
The U.S. Food and Drug Administration approved Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery.