Amarin Corp. provided an update, noting that the company is increasing revenue guidance for 2019 and is planning to expand the sales force for Vascepa due to faster-than-expected growth.
ImmunoGen shares fell after the company announced the slashing of 220 employees as part of an effort to reduce ongoing expenses while recovering from an FDA rejection of an ovarian cancer drug.
San Francisco is the first major city in the United States to ban the sale of e-cigarettes as officials look to control the rapid uptick in teenage use of nicotine devices made by companies such as Juul Labs Inc.
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The U.S. Food and Drug Administration issued a draft guidance on improving the diversity of patient populations in clinical trials.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.
Weekend Highlights from 2019 ASCO Annual Meeting
American Society of Clinical Oncology (ASCO), Analysis, Approvals, Clinical Data, Clinical Trials, Endocrine Therapy, Epidermal Growth Factor Receptor (EGFR), FDA, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Monoclonal Antibodies, Oncology, R&D, Relapse/Refractory Multiple Myeloma, Stage III non-small cell lung cancer (NSCLC), UnresectableThere 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.