Approvals
There are a few upcoming approval dates for several companies this week. Let’s take a look at the companies and their products awaiting approval.
The U.S. Food and Drug Administration (FDA) granted Genentech’s Tecentriq triple combination with Avastain (bevacizumab), paclitaxel and carboplatin (chemotherapy) Priority Review for first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
Approximately 25 percent of adults in the United States will deal with some form of mental illness within a given year. It’s also estimated that many of the people who experience these problems may never report it or seek help.
The U.S. Food and Drug Administration (FDA) approved Portola Pharmaceuticals’ Andexxa, an antidote for blood thinners rivaroxaban and apixaban.
According to Biosimilarpipeline, more than 660 companies worldwide have about 700 biosimilars in development.
Shares of Newton, Mass.-based Karyopharm Therapeutics is skyrocketing in premarket trading after the company announced late Monday it will seek U.S. Food and Drug Administration approval for its investigational drug selinexor following strong top-line results from a Phase IIb trial.
The U.S. Food and Drug Administration (FDA) cleared Haifa, Israel-based Pluristem Therapeutics’ Investigational New Drug (IND) application for PLX-R18 to treat acute radiation syndrome (ARS).
Novartis released new information that showed siponimod consistently reduced the risk of confirmed disability progression in secondary progressive multiple sclerosis (SPMS) patients.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations.
In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application for ALKS 5461. The FDA rejected the NDA at the end of March over a lack of data.
PRESS RELEASES