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46 New Drugs: The Number of New Drugs Marketed in 2017 Set a New Record for Recent 20 Years Dophine
January 03, 2018
FDA approved the marketing of 46 new drugs in total by December 21, 2017, successfully setting a new review record for the recent 20 years.
FDA Accepts Seattle Genetics' BLA and Grants Priority Review for Adcetris biospace
January 03, 2018
FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS (Brentuximab Vedotin) in Frontline Advanced Hodgkin Lymphoma
4 Biotechs Ready to Kill the Market in 2018 biospace
January 02, 2018
The NASDAQ Biotechnology Index has reported a gain of 19.4 percent this year, a rebound from last year’s drop of 19.2 percent.
5 Biotechs Awaiting FDA Decisions in January 2018 biospace
December 29, 2017
From 1997 through 2013, there was an average of 27 novel drugs approved in the U.S. per year. This year, 46 drugs were approved by the U.S. Food and Drug Administration (FDA)
FDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Cannabidiol (CBD) Oral Solution as Invest biospace
December 28, 2017
Insys Therapeutics (NASDAQ: INSY) announced today that the U.S. Food and Drug Administration (FDA) has approved the company's oral solution of cannabidicol (CBD) for the treatment of Prader-Willi Syndrome
FDA Extends Review Date of Portola's AndexXa BLA App biospace
December 28, 2017
Portola Pharmaceuticals, (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) will extend its review of the Biologics License Application (BLA) for AndexXa® (andexanet alfa) by 90 days.
Shire Plans to Hire for its new Manufacturing Site in Georgia biospace
December 28, 2017
Shire filed its first submission to the U.S. Food and Drug Administration (FDA) for its new plasma manufacturing site in Covington, Georgia.
FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA americanpharmaceuticalreview
December 27, 2017
Merck KGaA announced the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC).
3 FDA topics to watch in 2018 statnews
December 27, 2017
As the year winds down, STAT reporters are taking a look at the stories they’re most eager to track in 2018. Find all our “three to watch” series here.
FDA Proposes Easing of Medical Device Malfunctioning Reporting biospace
December 26, 2017
The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.

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