NEW YORK (TheStreet) -- It's been awhile since I updated the FDA drug approval calendar. Here's the latest list of drugs under FDA review. Included as well are relevant FDA advisory panel dates.
Enjoy.
May 2014:
Biogen Idec (BIIB)
Plegridy for multiple sclerosis
May 21
Eli Lilly (LLY)and Dyax (DYAX)
Ramucirumab for gastric cancer
May 23
Durata Therapeutics (DRTX)
Dalbavancin for skin infections
May 26
(An FDA advisory panel in March voted to recommend approval.)
Omeros (OMER)
OMS302 for ocular inflammation
May 30
June 2014:
BioDelivery Sciences (BDSI)
Bunavail for opioid addiction
June 6
Exact Sciences (EXAS)
Cologuard for colon cancer screening
June 6
Keryx Pharmaceuticals (KERX)
Zerenex for hyperphosphatemia (kidney dialysis)
June 6
Orexigen Therapeutics (OREX)
Contrave for obesity
June 10
June 11-12
FDA advisory committee meeting to discuss treatments for opioid-induced constipation
AstraZeneca (AZN) and Nektar Therapeutics (NKTR) - naloxogel
Salix Pharma (SLXP) -- Relistor
Biogen Idec
Eloctate for hemophilia A
June 12
Cubist Pharma (CBST)
Tedizolid for skin infections
June 20
July 2014:
MannKind (MNKD)
Afrezza for diabetes
July 15
July 24
FDA advisory panel
NPS Pharmaceuticals (NPSP)
Natpara for hypoparathyroidism July 24
Anacor Pharma (ANAC)
Tavaborole for toe fungus
July 29
August 2014:
Medicines Co. (MDCO)
Oritavancin for skin infections (MRSA)
Aug. 6
Spectrum Pharmaceuticals (SPPI)
Belinostat for peripheral T-cell lymphoma
Aug. 8
Regeneron Pharmaceuticals (REGN)
Eylea for diabetic macular edema (expansion of label)
Aug. 18
September 2014:
Gilead Sciences (GILD)
Idelalisib for indolent non-Hodgkin's lymphoma
Sept. 11 (pending FDA acceptance of priority review)
AstraZeneca and Nektar Therapeutics
Naloxegol for opioid-induced constipation
Sept. 16
Celgene (CELG)
Otezla for psoriasis (expansion of label)
Sept. 23
October 2014:
NPS Pharmaceuticals (NPSP)
Natpara for hypoparathyroidism
Oct. 24
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