Regulatory
Day One Biopharmaceuticals announced positive early data assessing tovorafenib as a once-a-week treatment in people aged six months to 25 years with relapsed or progressive pediatric low-grade glioma.
On Tuesday, Stealth Biotherapeutics announced that it plans to meet with the FDA to discuss a potential NDA for its therapeutic, elamipretide, which is intended to treat Barth syndrome.
While a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe, a number of biotechs are continuing to develop vaccines to use as booster shots.
For the second straight day, the FDA’s Cell, Tissue and Gene Therapies Advisory Committee voted unanimously to approve a bluebird lentiviral vector (LVV) gene therapy.
The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals.
Bavarian Nordic announced the U.S. Biomedical Advanced Research and Development Authority has ordered an additional 500,000 doses of its monkeypox vaccine, Jynneos.
Following a marathon session of the FDA’s Cell, Tissue and Gene Therapies Advisory Committee, bluebird bio passed its first critical hurdle in approval for the lentiviral vector gene therapy, eli-cel.
The FDA plans to review changes to Novavax’s manufacturing process before it authorizes its vaccine.
Bluebird bio faces a two-day crucible as the U.S. Food and Drug Administration’s Cell, Tissue and Gene Therapies Advisory Committee will give two lentiviral vector gene therapies a thumbs up or down.
The FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
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