Food and Drug Administration (FDA)
NEWS
Cases of monkeypox are growing at an alarming rate and Bavarian Nordic, the company that owns one of the two approved vaccines, may no longer be able to keep up.
The approval, which was made under Priority Review, is a watershed moment in gene therapy as it marks the first FDA green light for a lentiviral vector.
The FDA expects to foster innovation and competition among manufacturers, which would lower the prices of hearing aids without compromising their quality.
Novavax seeks EUA for COVID-19 Booster, a 100-year-old TB vaccine may protect against the disease and public health officials struggle with fall planning.
This week holds moments of truth for Provention’s type 1 diabetes drug and bluebird bio’s gene therapy for beta-thalassemia. Amicus and Incyte are coming up at the end of the month.
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC.
MaaT Pharma announced that the U.S. FDA has maintained the clinical hold on MaaT013, its candidate for patients with steroid-resistant acute graft-versus-host disease.
CRD’s CRD-TMH-001 is expected to upregulate an alternate form of the dystrophin protein with CRISPR technology and stabilize or reverse the symptoms associated with DMD.
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