NDA

Video game developer Rocksteady has lifted a portion of the non-disclosure agreement (NDA) on the closed alpha for "Suicide Squad: Kill the Justice League" following media previews. While publications expressed reservations about the game, Rocksteady — owned by Warner Bros....

Shares of Alkermes Plc (NASDAQ: ALKS) lost more than 20 percent early Monday morning after the U.S. Food and Drug Administration said it won't review the company's therapy ALKS-5461. What Happened Alkermes, which mostly focuses on treatments for central nervous system diseases, said...

PTC Therapeutics, Inc. (NASDAQ: PTCT) plunged as low as 4 percent off Thursday’s highs as traders circulated a report citing termination of the firm’s 2A ataluren study for Duchenne and Becker muscular dystrophies. However, a company spokesperson clarified that this was “very old...

Shares of TherapeuticsMD Inc (NYSE: TXMD), a healthcare company that focuses on creating and commercializing products for women, fell more than 11 percent Monday morning after the company announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration. The...

Micro-cap specialty pharmaceutical company AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) announced Monday the FDA accepted its New Drug Application for DSUVIA, its treatment for moderate-to-severe acute pain in medically supervised settings. In addition, the federal agency set a PDUFA date of Oct. 12,...

The strongest catalysts for a pharma stock are the various milestones on the road to FDA approval for new drugs. For new investors, they’ll often see a stock rise astronomically, but, when they go to make sense of the reasons for the jump, they’re greeted with unfamiliar acronyms. Let...

Shares of Clovis Oncology Inc (NASDAQ: CLVS) lost more than 8 percent on Friday after the company confirmed that the FDA posted briefing documents ahead of the Oncologic Drugs Advisory Committee (ODAC) meeting to discuss accelerated approval of the New Drug Application (NDA) for rociletinib. The...

Slow down a minute Endo Pharmaceuticals Holdings Inc (NASDAQ: ENDP) - there’s already a generic Lipoderm skin patch like the one you just submitted an NDA (new drug application for). At least that’s the story from Watson Laboratories Inc. (NYSE: WPI), which recently notified Endo Pharmaceuticals...