Government

Two weeks after the pharmaceutical industry predicted dire consequences for innovation if the prescription price reduction plan proposed by House Speaker Nancy Pelosi passes, the White House is now echoing those concerns but suggesting even worse outcomes than industry analysts predict.
FDA
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
In March, the FDA issued a Complete Response Letter for Zynquista as a treatment for type 1 diabetes.
Cardiovascular disease is currently the leading cause of death globally.
The companies are facing questions in a criminal probe regarding their marketing distribution practices related to the sale of opioids.
The government said Petit and former Chief Operating Officer William Taylor engaged in a scheme to “fraudulently inflate” the revenue of MiMedx.
FDA
Previously, Toujeo was approved only for adults aged 18 years and older.
Tetra Bio-Pharma Inc., announced that the U.S. Food and Drug Administration has authorized the advancement of Plenitude, the company’s clinical trial for its investigational therapeutic QIXLEEF™, for the treatment of uncontrolled pain in advanced cancer patients.
Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA
As we begin the final month of 2019, the U.S. Food and Drug Administration has several PDUFA dates to approve drug applications.
PRESS RELEASES