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February 17, 2024
AstraZeneca?s TAGRISSO® with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated...
February 16, 2024
– Priority review granted, with a review goal date of June 21, 2024 ...
February 16, 2024
Sarepta's Elevidys efficacy supplement accepted for Duchenne muscular dystrophy treatment expansion, potential $1 billion yearly opportunity. FDA review goal: June 21, 2024.
February 16, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain...
February 16, 2024
FDA approves first treatment for severe frostbite; Eohilia gains approval to treat eosinophilic esophagitis; MDMA accepted for Priority Review for PTSD; novel treatment to be reviewed for prurigo nodularis, atopic dermatitis; OTC pulse oximeter device is cleared.
February 16, 2024
(RTTNews) - Sarepta Therapeutics, Inc. (SRPT) announced on Friday that it has been granted Priority Review status by the FDA for its Efficacy Supp...
February 16, 2024
The FDA approved Amtagvi, the first cellular therapy for the treatment of adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
February 16, 2024
The FDA approved a new medication for the reduction of allergic reactions that may occur with accidental exposure to one or more foods. Patients who take this medication must continue to avoid foods they are allergic to.
February 16, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a...