Sarepta Says FDA Accepted Efficacy Supplement To BLA For Elevidys
(RTTNews) - Sarepta Therapeutics, Inc. (SRPT) announced on Friday that it has been granted Priority Review status by the FDA for its Efficacy Supp...
Source: businessinsider.com
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FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma
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.
Source: fda.gov
FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure
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.
Source: fda.gov
FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a...
Source: prnewswire.com