FDA Accepts GW Pharma's Epidiolex NDA With Priority Review for Lennox-Gastaut Syndrome and Dravet…
The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018. Source: BioSpace
The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018. Source: BioSpace
It was a pretty good year for the stock market, but how about for biotech stocks? Source: BioSpace
The deal was originally inked on Jan 17, 2014. Source: BioSpace
The agency inspected the plant from May 15 to May 24, 2017, and observed that staffers at the plant were basically gaming the quality control system. Source: BioSpace
Approximately 5.9 million shares were necessary for the tender to be accepted. Source: BioSpace
After the transaction, it will be NovaBay's largest shareholder with 6.6 million shares, 37% of the total. Source: BioSpace
The cost of a vital cancer drug has gone up 15-fold in four years after its new owner hiked prices on nine separate occasions. Source: BioSpace
Shire filed its first submission to the FDA for its new plasma manufacturing site in Covington, Georgia. Source: BioSpace
Novartis announced today that the FDA approved the inclusion of Treatment-free Remission data in the Tasigna U.S. product label. Source: BioSpace
2018 is the year for Rakesh Kapoor to show he's worth it. Source: BioSpace