Keeping Track: Rexulti, Iressa Approved; Takeda Submits Oral Myeloma Drug Ixazomib
The latest drug development news and highlights from our FDA Performance Tracker.
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Will Alkermes Data Package Support ALKS 5461 Approval?
Alkermes revealed successful completion of its third Phase III trial for the depression drug ALKS 5461 as well as a risky plan to seek FDA approval based on two negative and one positive late-stage study.
AstraZeneca’s Iressa, Now Resurrected, Faces Daunting U.S. EGFR Market
AstraZeneca sees an edge on safety for Iressa, which was traditionally perceived as having attractive tolerability relative to other EGFR inhibitors, but firm still has a tough road competing against the omnipresent Tarceva.
Keeping Track: More Rx-To-OTC Switches On Deck After US FDA’s OTC Narcan Approval; Iovance Looks To Bring Cell Therapy To Melanoma
The latest drug development news and highlights form the Pink Sheet’s US FDA Performance Tracker.