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.
Endo International plc submitted a Biologics License Application to the U.S. Food and Drug Administration for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
Morris Plains, N.J.-based Immunomedics announced that the company’s president, chief executive officer and board member, Michael Pehl, was stepping down for personal reasons.
The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.
The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.
2018 was a record year for biotech initial public offerings (IPOs), but 2019 is off to a slow and rocky start because of the government shutdown.