We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is asking a federal judge to dismiss a lawsuit brought by six agency scientists who say they were subjected to retaliatory personnel actions as punishment for reporting device safety concerns to Congress and the U.S. Office of Special Counsel (OSC).
Read More
Cispharma has received a Form 483 with several manufacturing observations, including a lack of evidence that a distributed portion of a lot was acceptable.
Read More
The FDA will issue guidance detailing what information drugmakers should share with contract manufacturing organizations (CMO) hired to work on their products, FDA officials say.
Read More
Noven Pharmaceuticals reported positive data from separate 12- and 24-week Phase III trials evaluating low-dose mesylate salt of paroxetine for reducing the frequency and severity of moderate-to-severe vasomotor symptoms associated with the menopause.
Read More
Takeda Pharmaceutical and Millennium: The Takeda Oncology Company have announced that Takeda Bio Development Center has initiated a Phase III clinical trial in Japan, Hong Kong, South Korea and Taiwan, evaluating motesanib in combination with chemotherapy in patients with advanced non-squamous non-small cell lung cancer.
Read More
A federal judge sentenced Abbott Laboratories to pay $700 million in fines and other costs for illegal marketing of its drug Depakote, in connection with a previously announced settlement, the U.S. Justice Department said.
Read More
Merck’s investigational once-weekly treatment for Type 2 diabetes significantly lowered blood sugar in a Phase IIb study compared with a placebo.
Read More