Bavarian Nordic enters into an agreement to sell for $160 million a priority review voucher that was awarded for gaining approval of its chikungunya v...
A Texas federal judge rules FDA acted properly in removing Novo Nordisks Ozempic and Wegovy from its drug shortage list.
Former FDA commissioner Scott Gottlieb expects FDA will reevaluate Sareptas approval of Duchenne muscular dystrophy gene therapy Elevidys based on two...
FDA Webview closes and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth.
FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-relate...
Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies away from DTC advertis...
FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.
FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...
