August is a busy month on the U.S. Food and Drug Administration)’s calendar, including a target action date for Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab), dosed concomitantly with a limited course of chemotherapy, for the first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
The U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the supplemental Biologics License Application for Arzerra (ofatumumab) as a treatment for patients with relapsing multiple sclerosis.
The U.S. Food and Drug Administration approved a supplemental Biologics License Application for Eli Lilly and Company’s Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
All of the world’s top 10 pharmaceutical companies have established substantial operations in Ireland and from 2003 to today, there has been dynamic growth of biologics manufacturing in Ireland, according to IDA Ireland.
France-based DBV Technologies released positive long-term data that could boost the chances of U.S. FDA approval for the company’s Viaskin Peanut allergy treatment.
Sanofi is pressing the U.S. Food and Drug Administration to keep the company’s patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.
Leeds, UK-based 4D Pharma and Merck/MSD are developing Live Biotherapeutics vaccines, a new class of medicines.