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The biologics license application for denileukin diftitox has been resubmitted to the FDA for the treatment of cutaneous T-cell lymphoma after at least 1 prior systemic therapy. ....
Stephen Harrison, MD, provides insight into the use of resmetirom for NASH with fibrosis ahead of the thyroid hormone receptor-β selective agonist’s March 14 PDUFA date. ....
The year 2024 has begun on a muted note in terms of FDA approvals, with only one novel drug getting endorsed in January. Let's take a look at the biotech companies that are awaiting FDA word on their drug candidates in February. ....
Rare disease therapeutics company Zevra Therapeutics, Inc. (ZVRA) announced Monday that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class treatment for Niemann-Pick disease type C. ....
– PDUFA goal date is May 14, 2024 COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14 ....