Akorn Inc. received a warning letter from the U.S. Food and Drug Administration regarding a manufacturing facility in New Jersey, the latest in a string of setbacks for the generic drugmaker, sending the company’s shares down nearly 13 percent.
Concern about clinical trial transparency, or more accurately the lack of transparency, is an ongoing problem. A new report shows that the lack of transparency also extends to post-marketing commitments that companies agreed to, following regulatory approval of a drug.
Catalyst Pharmaceuticals Inc., under fire for a high price tag on a rare disease drug, sued the U.S. Food and Drug Administration to challenge the recent approval of a lower-cost rival medicine.
The U.S. Food and Drug Administration issued a draft guidance on improving the diversity of patient populations in clinical trials.
Flow, a medical device company, launched a medication-free treatment for depression comprising a brain stimulation headset and therapy app.
There was a flurry of activity during the first few days of the American Society of Clinical Oncology, with multiple presentations made showing the benefits of various oncology treatments.
New interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that Biogen’s investigational treatment diroximel fumarate was generally well tolerated in people with relapsing MS.
San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.
With an opioid molecule awaiting regulatory review, Nektar Therapeutics announced the launch of Inheris Biopharma, which will be responsible for the commercialization of NKTR-181.
Boehringer Ingelheim’s SENSCIS Phase III clinical trial met the primary endpoint for nintedanib in patients with SSc-ILD.