The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
The U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the Biologics License Application (BLA) for Regeneron Pharmaceuticals Inc.’s REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
AstraZeneca’s Fasenra (benralizumab) hit a roadblock in attempting to expand the medicine’s indications when the U.S. Food and Drug Administration issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Henderson, Nev.-based Spectrum Pharmaceuticals.
In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.
The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.
A look at the U.S. Food and Drug Administration’s drug approval review calendar.
Shares of bluebird bio were down in trading after the U.S. Food and Drug Administration declined to review a Biologics License Application for the experimental CAR-T treatment idecabtagene vicleucel for multiple myeloma co-developed with Bristol Myers Squibb.
A new report released by GlobalData showed that there was a 16 percent decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration during 2019
While the healthcare industry looks for ways to combat COVID-19, the beat goes on for drug manufacturers to continue developing and seeking marketing approval for medicines to treat many diseases and conditions. Here is a look at some of the most notable U.S. new drug approvals from Jan. 1 through April 17, 2020.