Phase III
Karuna Therapeutics’ KarXT and Acadia Pharmaceuticals’ pimavanserin are sparking hope that a treatment for the negative symptoms of schizophrenia could be on the horizon.
AbbVie and Johnson & Johnson will withdraw the accelerated approvals for Imbruvica in mantle cell lymphoma and marginal zone lymphoma, the companies announced Thursday.
Currently, there are no gene editing–based treatments on the market, but the technology continues its march toward potential FDA approval, with several products in mid- and late-stage trials.
Results from two late-stage trials showed the Merck-Eisai combo treatment failed to boost survival in two difficult-to-treat advanced cancers.
Phase III data for Pfizer’s respiratory syncytial virus vaccine candidate showed high levels of protection for older adults and infants.
AstraZeneca’s Imfinzi and Lynparza met primary endpoint markers in the Phase III DUO-O trial in advanced high-grade epithelial ovarian cancer, according to data released Wednesday.
The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
The Centers for Medicare and Medicaid Services released details about the patient registry it will require physicians to use to prescribe Leqembi, should it be approved by the FDA.
The FDA has approved the combination regimen of Merck’s Keytruda and Seagen and Astellas’ Padcev for the first-line treatment of locally advanced or metastatic urothelial carcinoma.
In a potential leap forward for sickle cell disease, Vertex moved closer to launching its one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
PRESS RELEASES