Incyte has withdrawn its New Drug Application (NDA) for parsaclisib, which is an investigational treatment for various types of lymphoma, including relapsed/refractory mantle cell lymphoma (MCL), follicular lymphoma, and marginal…
In a recent press release, biopharmaceutical company Mirum Pharmaceuticals, Inc. ("Mirum") shared that the company finished its rolling New Drug Application (NDA) submission. The NDA focuses around maralixibat, an investigational…
On January 13, 2021, pharmaceutical company Marinus Pharmaceuticals, Inc. ("Marinus") shared via press release that the FDA gave the company a positive response following efficacy and safety data from the…
In a late December 2020 press release, biopharmaceutical company Cerecor Inc. (“Cerecor”) announced the FDA acceptance of an Investigational New Drug Application (IND) for CERC-007. The human monoclonal antibody (mAb)…
COVID-19’s tentacles have invaded the New Drug Applications (NDAs) for 2020. A recent article in Fierce Pharma reported that the FDA has been especially vigilant in scrutinizing NDAs this year,…
In early November, global biotechnology company BioMarin Pharmaceutical Inc. ("BioMarin") announced the acceptance of its New Drug Application (NDA) for vosoritide. The investigational injectable treatment is designed to treat pediatric…
Earlier this week, Sarepta Therapeutics announced that the FDA approved a New Drug Application (NDA) for Casimersen (SRP-4045). The treatment, for patients with exon 45 amenable Duchenne muscular dystrophy (DMD),…
According to biotechnology Gilead Sciences, the FDA rejected a new drug application (NDA) for filgotinib. The drug, designed to treat patients with moderate to severe rheumatoid arthritis (RA), is known…
According to a recent press release, biotechnology company Cancer Prevention Pharmaceuticals (CPP) submit a New Drug Application (NDA) for accelerated approval of their drug therapy CPP-1X/sul to treat familial adenomatous…
According to CheckOrphan, Clinuvel Pharmaceuticals recently announced that their drug Scenesse has received a Prescription Drug User Fee Act (PDUFA) date from the FDA, set for July 8th of this…
According to a story by MarketScreener, pharmaceutical company Acer Therapeutics Inc. has submitted a New Drug Application (NDA) for its vascular Ehlers-Danlos syndrome (vEDS) drug Edsivo. The NDA was granted…
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