Skip to main content

Updated as of Jan. 6, 2014.

For your biotech trading adventures in the new year -- an FDA drug approval calendar for 2014.

The following calendar includes 34 FDA drug approval decisions and scheduled advisory panels from December 2013 through October 2014. I compiled the calendar using company reports, my own research and the remarkably useful services of


January 2014: Drug approval decisions

Bristol-Myers Squibb 
Dapagliflozin for Type 2 diabetes
Jan. 14

Vanda Pharmaceuticals (VNDA)
Hetlioz for non-24 sleep disorder
Jan. 31

FDA advisory panels:

Chelsea Therapeutics (CHTP)
Northera for orthostatic hypotension
Jan. 14

February 2014: Drug approval decisions

Chelsea Therapeutics
Northera for orthostatic hypotension
Feb. 14

Bristol-Myers Squibb
Metreleptin for lipodystrophy
Feb. 27

Biomarin (BMRN)
Vimizim for morquio syndrome
Feb. 28

Pharmacyclics (PCYC) and Johnson & Johnson (JNJ)
Imbruvica for chronic lymphocytic leukemia
Feb. 28

March 2014: Drug approval decisions

Celgene (CELG)
Apremilast for psoriatic arthritis
March 21

Scroll to Continue

TheStreet Recommends

April 2014: Drug approval decisions

Biogen Idec (BIIB)
Alprolix for hemophilia B 
Jan. 3

MannKind (MNKD)
Afrezza for Type 1 and 2 diabetes
April 15

GlaxoSmithKline (GSK)
Abiglutide for diabetes
April 15

Santarus (SNTS)
Ruconest for hereditary angioedema
April 16

Pozen (POZN)
PA32540 & PA8140 for heart disease 
Jan. 24

Click ahead for more FDA drug approval decision dates

May 2014: Drug approval decisions

AstraZeneca (AZN)
Epanova for hypercholesterolemia
May 5

Gilead Sciences
Idelalisib for indolent non-Hodgkin's lymphoma
May 11 (pending FDA acceptance of priority review)

Biogen Idec
Plegridy for multiple sclerosis
May 21

Durata Therapeutics (DRTX)
Dalbavancin for skin infections
May 26

June 2014: Drug approval decisions

Omeros (OMER)
OMS302 for ocular inflammation
June 1

Eli Lilly (LLY)
Ramucirumab for gastric cancer
June 3

BioDelivery Sciences (BDSI)
Bunavail for opioid addiction
June 7

Keryx Pharmaceuticals (KERX)
Zerenex for hyperphosphatemia (kidney dialysis)
June 7

Biogen Idec
Eloctate for hemophilia A
June 12

Cubist Pharma (CBST)
Tedizolid for skin infections
June 22 (pending FDA acceptance of priority review)

July 2014: Drug approval decisions

Anacor Pharma (ANAC)
Tavaborole for toe fungus
July 29

September 2014: Drug approval decisions

AstraZeneca and Nektar Therapeutics (NKTR)
Naloxegol for opioid-induced constipation
Sept. 16

October 2014: Drug approval decisions

NPS Pharmaceuticals  (NPSP)
Natpara for hypoparathyroidism
Oct. 24

-- Reported by Adam Feuerstein in Boston.

Follow Adam Feuerstein on Twitter.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

click here

to send him an email.