Regulatory
The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.
The approval is a first for the the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The drug has a list price of $225,000.
SMA is a severe neuromuscular disease caused by a mutation in the SMN1 gene, which codes for SMN, a protein necessary for motor neuron function.
Curbing the opioid crisis will continue to be a key focus for the FDA. Ned Sharpless talked about new packaging rules that are expected to help stem the concerns about too many opioids on the streets.
The Management team of MorphoSys AG will host a conference call and webcast on May 8, 2019 at 2:00pm CEST (1:00pm BST; 8:00am EDT) to present MorphoSys’s first quarter interim statement 2019 and provide an outlook for 2019.
A recent detailed inspection by the United States Department of Agriculture has again found that Primate Research Organization Alpha Genesis is in full compliance with ALL regulations and standards of the Animal Welfare Act, company officials announced.
Neos Therapeutics, Inc. announced that it will report its first quarter 2019 financial results prior to the opening of U.S. financial markets on Thursday, May 9, 2019.
MyoKardia, Inc. announced that it will report first quarter 2019 financial and operating results on Thursday, May 9, 2019.
Dengvaxia is approved for dengue disease caused by serotypes 1-4 in people 9 through 16 years of age who are living in areas of the U.S. who have had a laboratory-documented previous infection.
Blythedale Children’s Hospital and Burke Neurological Institute announce the appointment of Dianna E. Willis, Ph.D., as Director of Research for the Burke-Blythedale Pediatric Neuroscience Research Collaboration.
PRESS RELEASES