FDA
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
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 Inflation Reduction Act contains provisions designed to influence drug prices. These policies might affect drug development and the prioritization of new drugs.
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.
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
Ravi B. Parikh discussed how new FDA guidance on accelerated approval for cancer drugs will affect the space.
The FDA approved Pharming’s leniolisib, now to be marketed as Joenja, for the treatment of the ultra-rare disease-activated phosphoinositide 3-kinase delta syndrome, the company announced Friday.
Wednesday, the FDA approved Cidara Therapeutics and Melinta Therapeutics’ Rezzayo (rezafungin) injection to treat candidemia and invasive candidiasis.
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