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.
MorphoSys AG announced that the U.S. Food and Drug Administration accepted filing of MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab, the company’s investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).
Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
Roche Group member Genentech announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
The U.S. Food and Drug Administration’s busy schedule for drug reviews includes six supplemental BLAs for Merck’s blockbuster oncology brand Keytruda.