logo
Plus   Neg
Share
Email

Biotech Stocks Facing FDA Decision In May

calendar-042718-lt.jpg

Another busy month at the FDA is coming to an end, and it's that time again to take a look at the upcoming action dates of approval, and panel review dates.

Before we take a look at the companies expecting a decision in May, here's some of what happened on the regulatory front in April.

On April 10, 2018, the FDA cleared Acuvue Oasys contact lenses, the first contact lens with light-adaptive technology to correct nearsightedness and farsightedness.

Ultragenyx Pharmaceutical Inc.'s (RARE) Crysvita was greenlighted on April 17th, becoming the first FDA-approved therapy for rare inherited form of rickets, x-linked hypophosphatemia.

On April 20th, the FDA authorized BRUKER MALDI Biotyper CA system, the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.

On a more official front, the FDA Commissioner Scott Gottlieb, on April 24th, delivered his remarks on Fiscal Year 2019 budget request for FDA. In his remarks, he outlined steps aimed at making the drug review process more efficient, modern and scientifically rigorous.

The President's 2019 Budget requests $5.8 billion in total resources for FDA - which is an increase of $663 million or 13 percent above the FY 2018 Annualized Continuing Resolution.

Now, let's take a look at the biotech stocks that await a ruling from the FDA in May 2018.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT
>