Food and Drug Administration (FDA)
NEWS
The FDA said the approval of Teva’s product is the first generic naloxone nasal spray for use in a community setting by individuals without medical training.
Just as Novartis and AveXis’ gene therapy, Zolgensma (onasemnogene abeparvovec-xioi) for spinal muscular atrophy (SMA) is progressing toward approval, a second patient death was reported.
Akorn secured approval for a post-operative eye drop, as well as a generic over-the-counter version of GSK’s Flonase.
FDA grants elafibranor Breakthrough Therapy Designation, based on Phase 2 data, for treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA
Director Peter Marks said FY18 was productive and exciting as the FDA department continued to support the advancement of 21st century medicine.
In the first quarter of 2019, more than 30 life science companies* announced expansions, new locations, increased funding, new trial and product launches and various other news pointing to a growing industry.
As Ned Sharpless takes over as acting commissioner of the U.S. Food and Drug Administration, he is not planning any disruptions or course corrections to the federal regulatory agency.
Company on Track to Submit NDA to FDA in Mid-2019
Karolinska Development’s portfolio company Aprea Therapeutics has from FDA received an Orphan Drug Designation for APR-246 for the treatment of patients with Myelodysplastic Syndromes having a TP53 mutation.
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