Thursday, the FDA pushed back its target action date by three months for Daiichi Sankyo’s investigational acute myeloid leukemia (AML) drug quizartinib, citing updates to the proposed Risk Evaluation and Mitigation Strategies (REMS).
Tag Archive for: U.S. Food and Drug Administration (FDA)
Operation Warp Speed worked so well to accelerate the development of COVID-19 vaccines the FDA now has its sights set on a similar initiative for rare disease treatments.
Bluebird bio Inc. said on Monday it has submitted a marketing application to the U.S. Food and Drug Administration for its gene therapy to treat sickle cell disease.
U.S. Supreme Court Justice Samuel Alito on Wednesday extended by two days a temporary block on limits set by lower courts on access to the abortion pill mifepristone in a challenge by anti-abortion groups to the drug’s federal regulatory approval.
AbbVie wins FDA approval for new migraine indication Published: Apr 19, 2023 By Tristan Manalac BioSpace The FDA has approved an expanded indication for AbbVie’s Qulipta (atogepant) to treat patients […]
The FDA has approved Gamida Cell’s omidubicel-onlv, now to be marketed as Omisirge, in patients over 12 years of age with blood cancers, the company announced Monday.
The U.S. Food and Drug Administration on Tuesday authorized a second dose of Omicron-targeting COVID-19 vaccines for older adults as well as those with a weak immune system.
Sarepta Therapeutics Inc.’s shares fell more than 6% on Thursday as Stat News reported that the U.S. health regulator’s staff were inclined to reject the company’s gene therapy which is currently under review.
Merck KGaA said on Wednesday the U.S. Food and Drug Administration (FDA) had paused the initiation of new patients on its multiple sclerosis evobrutinib drug, knocking the German drugmaker’s share price.
Abortion opponents on Tuesday urged a U.S. appeals court to allow the suspension of Food and Drug Administration’s approval of the abortion pill mifepristone, in a case with potentially far-reaching impact on how the government regulates medicine.
