Government

The U.S. Food and Drug Administration approved Impact’s Inrebic for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone marrow.

Wrapping up the month of August, there are technically four PDUFA dates on the calendar, although one was approved two months early and another may be delayed as the U.S. Food and Drug Administration reevaluates its policies regarding opioid pain medications. Here’s a look.

The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

Label-free, 3-D holotomography imaging enables researchers to observe morphological and chemical alterations of host cells without transfection or dye staining

The Democratic senators called it “unconscionable” that AveXis and its parent company Novartis would include manipulated data in order to rush a product to market.

Now that July has come and gone, the U.S. Food and Drug Administration is back to work approving drugs. This week marks three PDUFA target action dates, although one has already been rejected and another hit a snag that doesn’t appear to affect the decision date.

Before it finalizes the guidance, the FDA is seeking comment from drugmakers about the proposed plans.

This is an area where the U.S. is considering changes as well. Earlier this year, the U.S. Department of Health and Human Services proposed a new policy called the International Pricing Index.

Researchers from Singapore and the United States are focused on a novel drug candidate with marine origins as a new method to prevent or treat vision loss.

Researchers from A*STAR’s Institute of Bioengineering and Nanotechnology have successfully developed an innovative nanocarrier derived from green tea catechins, which can deliver anti-cancer drugs in a targeted and effective fashion.