bluebird bio Inc. announced updated results from the clinical development program for the company’s investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study.
The U.S. Food and Drug Administration expanded the emergency use authorization of Gilead Inc.’s experimental antiviral Covid-19 treatment remdesivir to allow the product’s use in all hospitalized Covid-19 patients.
The Trump administration will purchase 150 million rapid coronavirus tests from Abbott Laboratories for about $750 million, a White House spokeswoman said.
The U.S. Food and Drug Administration approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1%).
The U.S. Food and Drug Administration approved FoundationOne Liquid CDx, a new pan-tumor liquid biopsy test that is indicated for use as a companion diagnostic for four FDA-approved precision therapies.
Novavax Inc. expects filing for approval of the company’s Covid-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny.
The U.S. Food and Drug Administration issued Emergency Use Authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card rapid test for detection of Covid-19 infection.
The U.S. Food and Drug Administration removed a boxed warning about increased risk of leg and foot amputations with Johnson & Johnson’s diabetes drug Invokana.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for Tricida’s experimental chronic kidney disease treatment veverimer.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.