Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of… Read More
Company is well capitalized after signing $50 million working capital credit facility and recent $30 million equity raise
Favorable outcome at Markman hearing in pending CINVANTI® ANDA… Read More
| (PHOTO: REUTERS)The Food and Drug Administration has indefinitely postponed a meeting scheduled for this Friday to review an application for the first over-the-counter birth control pill… Read More
We are at mid-year, a good time to check in and see how we are doing on a number of fronts – including where we are with new drug approvals. Over the years, Congress has acted to enhan… Read More
New York, New York--(Newsfile Corp. - April 1, 2022) - Pomerantz LLP announces that a class action lawsuit has been filed against Fennec Pharmaceuticals Inc. ("Fennec" or the "Company") (NAS… Read More
There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new… Read More
New York, New York--(Newsfile Corp. - April 10, 2021) - Pomerantz LLP announces that a class action lawsuit has been filed against Kadmon Holdings, Inc. ("Kadmon" or the "Company") (NASDAQ:… Read More
As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of so… Read More
Empty FDA Advisory Committee Meeting RoomEarlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions t… Read More
During the past few years, there has been a renewed focus on facilitating the development of new medicines by providing new mechanisms to streamline the review process and get drugs to p… Read More
At the mid-year point, I usually do a check-in to see how we are doing on new drug approvals and how it compares to years gone by. I am quite tardy checking in on that front, so let’s… Read More
—FDA PDUFA dates December 27 & 28, 2016— CHAPEL HILL, N.C., Nov. 04, 2016 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused… Read More