Regulatory
The FDA calendar has only one PDUFA data scheduled for the next couple weeks. On Thursday, April 11, the U.S. Food and Drug Administration (FDA) and Merck & Co. have a target action date for their supplemental Biologics License Application (sBLA) for Keytruda
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.
Sino-American relations continue to show signs of strain after the administration of President Donald Trump ordered the Chinese majority owner of healthcare company PatientsLikeMe to sell his stake.
The Pennsylvania-based company disagrees with the FDA’s analysis of its clinical data and will seek to work with the agency for approval.
In January 2019, the U.S. Food and Drug Administration (FDA) updated a 2015 draft guidance on rare diseases.
Phase 1/2 pheNIX Trial Would Represent First PKU Gene Therapy to Enter the Clinic
The shares are trading on XETRA, the electronic trading platform of Deutsche Börse.
The government charged the three companies with using charitable foundations they financially supported to finance copays of Medicare and Medicaid patients, which is a violation of law.
The current Spinraza cost is $750,000 for the first year and $375,000 for every year after for the life of the patient. It is approved for all forms of SMA.
With the clock winding down on his tenure at the U.S. Food and Drug Administration, Commissioner Scott Gottlieb continues to take aim at a number of concerns he has raised over the past two years, including the dangers of vaping and unsanctioned use of stem cells.
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